Devices, systems and methods for diagnosing and treating sinusitis andother disorders of the ears, nose and/or throat

ABSTRACT

Sinusitis, enlarged nasal turbinates, tumors, infections, hearing disorders, allergic conditions, facial fractures and other disorders of the ear, nose and throat are diagnosed and/or treated using minimally invasive approaches and, in many cases, flexible catheters as opposed to instruments having rigid shafts. Various diagnostic procedures and devices are used to perform imaging studies, mucus flow studies, air/gas flow studies, anatomic dimension studies, endoscopic studies and transillumination studies. Access and occluder devices may be used to establish fluid tight seals in the anterior or posterior nasal cavities/nasopharynx and to facilitate insertion of working devices (e.g., scopes, guidewires, catheters, tissue cutting or remodeling devices, electrosurgical devices, energy emitting devices, devices for injecting diagnostic or therapeutic agents, devices for implanting devices such as stents, substance eluting devices, substance delivery implants, etc.

RELATED APPLICATIONS

This patent application is a continuation of copending U.S. patentapplication Ser. No. 12/649,050 filed Dec. 29, 2009 which is acontinuation of U.S. patent application Ser. No. 10/829,917 filed Apr.21, 2004 and issued as U.S. Pat. No. 7,654,997 on Feb. 2, 2010, theentire disclosure of each such patent and patent application beingexpressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices and methodsand more particularly to minimally invasive, catheter based devices,systems and methods for treating sinusitis and other ear, nose & throatdisorders.

BACKGROUND

The human nose is responsible for warming, humidifying and filteringinspired air and for conserving heat and moisture from expired air. Thenose is also an important cosmetic feature of the face. The nose isformed mainly of cartilage, bone, mucous membranes and skin. The rightand left nostrils lead into right and left nasal cavities on either sideof the intranasal septum. The right and left nasal cavities extend backto the soft palate, where they merge to form the posterior choanae. Theposterior choanae opens into the nasopharynx. The roof of the nose isformed, in part, by a bone known as the cribriform plate. The cribriformplate contains numerous tiny perforations through which sensory nervefibers extend to the olfactory bulbs. The sensation of smell occurs wheninhaled odors contact a small area of mucosa in the superior region ofthe nose, stimulating the nerve fibers that lead to the olfactory bulbs.

The paranasal sinuses are cavities formed within the bones of the face.The paranasal sinuses include frontal sinuses, ethmoid sinuses,sphenoidal sinuses and maxillary sinuses. The paranasal sinuses arelined with mucous-producing epithelial tissue. Normally, mucous producedby the linings of the paranasal sinuses slowly drains out of each sinusthrough an opening known as an ostium, and into the nasopharnyx.Disorders that interfere with drainage of mucous (e.g., occlusion of thesinus ostia) can result in a reduced ability of the paranasal sinuses tofunction normally. This results in mucosal congestion within theparanasal sinuses. Such mucosal congestion of the sinuses can causedamage to the epithelium that lines the sinus with subsequent decreasedoxygen tension and microbial growth (e.g., a sinus infection).

The nasal turbinates are three (or sometimes four) bony processes thatextend inwardly from the lateral walls of the nose and are covered withmucosal tissue. These turbinates serve to increase the interior surfacearea of the nose and to impart warmth and moisture to air that isinhaled through the nose. The mucosal tissue that covers the turbinatesis capable of becoming engorged with blood and swelling or becomingsubstantially devoid of blood and shrinking, in response to changes inphysiologic or environmental conditions. The curved edge of eachturbinate defines a passageway known as a meatus. For example, theinferior meatus is a passageway that passes beneath the inferiorturbinate. Ducts, known as the nasolacrimal ducts, drain tears from theeyes into the nose through openings located within the inferior meatus.The middle meatus is a passageway that extends inferior to the middleturbinate. The middle meatus contains the semilunar hiatus, withopenings or ostia leading into the maxillary, frontal, and anteriorethmoid sinuses. The superior meatus is located between the superior andmedial turbinates.

Nasal Polyps:

Nasal polyps are benign masses that grow from the lining of the nose orparanasal sinuses. Nasal polyps often result from chronic allergicrhinitis or other chronic inflammation of the nasal mucosa. Nasal polypsare also common in children who suffer from cystic fibrosis. In caseswhere nasal polyps develop to a point where they obstruct normaldrainage from the paranasal sinuses, they can cause sinusitis.

Sinusitis:

The term “sinusitis” refers generally to any inflammation or infectionof the paranasal sinuses. Sinusitis can be caused by bacteria, viruses,fungi (molds), allergies or combinations thereof. It has been estimatedthat chronic sinusitis (e.g., lasting more than 3 months or so) resultsin 18 million to 22 million physician office visits per year in theUnited States.

Patients who suffer from sinusitis typically experience at least some ofthe following symptoms:

headaches or facial pain

nasal congestion or post-nasal drainage

difficulty breathing through one or both nostrils

bad breath

pain in the upper teeth

Proposed Mechanism of Sinus Pain & Diagnosis

The sinuses consist of a series of cavities connected by passageways,ultimately opening into the nasal cavity. As described previously, thesepassageways and cavities are formed by bone, but covered in mucosa. Ifthe mucosa of one of these passageways becomes inflamed for any reason,the cavities which drain through that passageway can become blocked.This trapping of mucous can be periodic (resulting in episodes of pain)or chronic. Chronically blocked passageways are targets of infection.Ultimately, it is the dimensions of the bony passageways and thicknessof the overlying mucosa and its chronicity that dictate the duration andseverity of sinus symptoms. Thus, the primary target for sinus therapyis the passageway, with the primary goal to regain drainage. Often CTwill not reveal these dimensional issues, especially when the patient isnot currently experiencing severe symptoms. Therefore there exists aneed to dynamically evaluate the sinus passageways under normalconditions, in response to challenging stimuli. As suggested herein, ifit would be possible to assess sinus disease and its dynamic component,one might better target therapy for sinusitis and possibly be able totreat patients in a more focused and minimally invasive manner. Suchfocus on the passageway and the use of flexible instrumentation suggestsan entirely new approach to sinus intervention: one utilizing flexiblecatheters and guidance tools, with passageway and cavity modifyingdevices capable of being delivered with minimal damage to thesurrounding tissues.

Deviated Septum:

The intranasal septum is a cartilaginous anatomical structure thatdivides one side of the nose from the other. Normally, the septum isrelatively straight. A deviated septum is a condition where thecartilage that forms the septum is abnormally curved or bent. A deviatednasal septum may develop as the nose grows or, in some cases, may resultfrom trauma to the nose. A deviated septum can interfere with properbreathing or may obstruct normal drainage of nasal discharge, especiallyin patient's whose nasal turbinates are swollen or enlarged due toallergy, overuse of decongestant medications, etc. Such interferencewith drainage of the sinuses can predispose the patient to sinusinfections.

A deviated nasal septum that interferes with proper function of the nosecan be surgically corrected by a procedure known as septoplasty. In atypical septoplasty procedure, an endoscope is inserted into the noseand the surgeon makes an incision inside the nose, lifts up the liningof the septum, and removes and straightens the underlying bone andcartilage that is abnormally deviated. Such surgical septoplastyprocedures can effectively straighten a deviated septum but, because thenasal cartilage has some memory, the septum may tend to resume itsoriginal deviated shape.

Reduction/Removal of Nasal Turbinates

Various surgical techniques, including endoscopic surgery, have beenused for reduction and/or removal of the inferior turbinate in patient'swhose inferior turbinate is chronically enlarged such that it isobstructing normal breathing and/or normal drainage from the paranasalsinuses. Typically, chronic enlargement of the inferior turbinates isthe result of allergies or chronic inflammation. Enlargement of theinferior turbinate can be especially problematic in patient's who alsosuffer from a deviated septum that crowds or impinges upon the softtissue of the turbinate. Thus, a septoplasty to straighten the deviatedseptum is sometimes performed concurrently with a reduction of theinferior turbinates.

Sinus Tumors

Most polyps are benign, but one form of a nasal polyp, known as aninverting papilloma, can develop into a malignancy. Unlike most benignpolyps, which typically occur on both sides of the nose, an invertingpapilloma is usually found on just one side. Thus, in cases where aunilateral polyp is observed, it is usually biopsied to determine if itis malignant. If an inverting papilloma is detected before it becomesmalignant and is removed completely, it will typically not recur.However, using the technology that has heretofore been available, it hassometimes been difficult to determine if the papilloma has been entirelyremoved unless and until regrowth of the polyp is observed on long termpost-surgical follow-up.

Various benign sinus tumors have also been known to occur, but arerelatively rare. The most common form of malignant sinus tumor issquamous cell carcinoma. Even with surgery and radiation treatment,squamous cell carcinoma of the paranasal sinus is associated with arelatively poor prognosis. Other types of malignant tumors that invadethe paranasal sinuses include adenocarcinoma and, more rarely, lymphomaand even more rarely, melanoma.

Facial Fractures

The most common cause of fractures of the facial bones is autoaccidents, but facial fractures are also frequently caused by sportsinjuries, industrial accidents, falls, assaults and gunshot wounds. Somefacial fractures involve bones that are accessible from inside the nasalcavities or paranasal sinuses. Notably, the nose is the most commonlyinjured facial structure due to its prominent position on the face.Thus, fractures of the nasal bone (with or without resultant deviatedseptum) are not uncommon. Other facial fractures such as fractures ofthe orbital floor and/or the ethmoid or frontal sinuses are alsoaccessible from inside the nose or sinuses. A common type of orbitalfloor fracture is a “blowout” fracture that typically results from blunttrauma to the eye where the force is transmitted downwardly causing therelatively thin bone that forms the floor of the orbit to fracturedownwardly. This can cause the periorbital tissues to herniate into themaxillary sinus and sometimes can also create a “trap door” of bone thatextends downwardly into the maxillary sinus.

Endoscopic Sinus Surgery and Other Current Procedures

Functional Endoscopic Sinus Surgery

The most common corrective surgery for chronic sinusitis is functionalendoscopic sinus surgery (FESS). In FESS, an endoscope is inserted intothe nose and, under visualization through the endoscope, the surgeon mayremove diseased or hypertrophic tissue or bone and may enlarge the ostiaof the sinuses to restore normal drainage of the sinuses. FESSprocedures can be effective in the treatment of sinusitis and for theremoval of tumors, polyps and other aberrant growths from the nose.Other endoscopic intranasal procedures have been used to removepituitary tumors, to treat Graves disease (i.e., a complication ofhyperthyroidism which results in protrusion of the eyes) and surgicalrepair of rare conditions wherein cerebrospinal fluid leaks into thenose (i.e., cerebrospinal fluid rhinorrhea).

Surgery to reduce the size of the inferior turbinates can beaccomplished with endoscopic visualization (with magnification wheredesired) and is typically performed with the patient under generalanesthesia. An incision is typically made in the mucosa that lines theturbinate to expose the underlying bone. Some quantity of the underlyingbone may then be removed. If selective removal of some of the mucosa orsoft tissue is also desired, such soft tissue can be debulked or removedthrough by traditional surgical cutting or by the use of other tissueablation or debulking apparatus such as microdebriders or lasers. Lessfrequently, chronically enlarged inferior turbinates have been treatedby cryotherapy. It is typically desirable to remove only as much tissueas necessary to restore normal breathing and drainage, as removal of toomuch tissue from the turbinates can impair the ability of the turbinatesto perform their physiological functions of warming and humidifyinginspired air and conserving warmth and moisture from expired air.Complications associated with inferior turbinate surgery includebleeding, crusting, dryness, and scarring.

In some patients, the middle turbinate is enlarged due to the presenceof an invading air cell (concha bullosa), or the middle turbinate may bemalformed (paradoxically bent). Severe ethmoid sinusitis or nasal polypscan also result in enlargement or malformation of the middle turbinates.Since a substantial amount of drainage from the sinuses passes throughthe middle meatus (i.e., the passage that runs alongside middleturbinate) any enlargement or malformation of the middle turbinate cancontribute to sinus problems and require surgical correction. Thus, insome FESS procedures carried out to treat sinusitis, the middle meatusis cleared (e.g., the polyps or hypertorophic tissue are removed)thereby improving sinus drainage. However, the middle turbinate caninclude some of the olfactory nerve endings that contribute to thepatient's sense of smell. For this reason, any reduction of the middleturbinate is typically performed in a very conservative manner with carebeing taken to preserve as much tissue as possible. In patients whosuffer from concha bullosa, this may involve removing the bone on oneside of an invading air sac. In the cases where the middle turbinate ismalformed, just the offending portion(s) of the turbinate may beremoved.

Extended Endoscopic Frontal Sinus Surgery

Because of its narrow anatomical configuration, inflammation of thefrontal sinuses can be particularly persistent, even after surgeryand/or medical therapy has resolved the inflammation in the otherparanasal sinuses. In cases of persistent inflammation of the frontalsinuses, a surgery known as a trans-septal frontal sinusotomy, ormodified Lothrop procedure, is sometimes performed. In this procedure,the surgeon removes a portion of the nasal septum and the bony partitionbetween the sinuses to form one large common drainage channel fordraining the frontal sinuses into the nose. This complicated procedure,as well as some other ear, nose and throat surgical procedures, cancarry a risk of penetrating the cranial vault and causing leakage ofcerebrospinal fluid (CSF). Also, some sinus surgeries as well as otherear, nose and throat procedures are performed close to the optic nerves,the eyes, and the brain and can cause damage to those structures. Tominimize the potential for such untoward complications or damage,image-guided surgery systems have been used to perform some complex headand neck procedures. In image guided surgery, integrated anatomicalinformation is supplied through CT-scan images or other anatomicalmapping data taken before the operation. Data from a preoperative CTscan or other anatomical mapping procedure is downloaded into a computerand special sensors known as localizers are attached to the surgicalinstruments. Thus, using the computer, the surgeon can ascertain, inthree dimensions, the precise position of each localizer-equippedsurgical instrument at any given point in time. This information,coupled with the visual observations made through the standardendoscope, can help the surgeon to carefully position the surgicalinstruments to avoid creating CSF leaks and to avoid causing damage tonerves or other critical structures.

Shortcomings of FESS

Although FESS continues to be the gold standard therapy for severesinuses, it has several shortfalls. Often patients complain of thepost-operative pain and bleeding associated with the procedure, and asignificant subset of patients remain symptomatic even after multiplesurgeries. Since FESS is considered an option only for the most severecases (those showing abnormalities under CT scan), a large population ofpatients exist that can neither tolerate the prescribed medications norbe considered candidates for surgery. Further, because the methodologiesto assess sinus disease are primarily static measurements (CT, MRI),patients whose symptoms are episodic are often simply offered drugtherapy when in fact underlying mechanical factors may play asignificant role. To date, there is no mechanical therapy offered forthese patients, and even though they may fail pharmaceutical therapies,no other course of action is indicated. This leaves a large populationof patients in need of relief, unwilling or afraid to take steroids, butnot sick enough to qualify for surgery.

One of the reasons why FESS and sinus surgery is so bloody and painfulrelates to the fact that straight instrumentation with rigid shafts areused. Due to the fact that the sinuses are so close to the brain andother important structures, physicians have developed techniques usingstraight tools and image guidance to reduce the likelihood ofpenetrating into unwanted areas. In an effort to target deep areas ofthe anatomy, this reliance on straight instrumentation has resulted inthe need to resect and remove or otherwise manipulate any anatomicalstructures that may lie in the path of the instruments, regardless ofwhether those anatomical structures are part of the pathology. With theadvances in catheter based technology and imaging developed for thecardiovascular system, there exists a significant opportunity to reducethe morbidity of sinus interventional through the use of flexibleinstrumentation and guidance.

If flexible tools could be developed such that sinus intervention may beable to be carried out with even less bleeding and post-operative pain,these procedures may be applicable to a larger group of patients.Further, as described here, flexible instrumentation may allow theapplication of new diagnostic and therapeutic modalities that have neverbefore been possible.

Laser or Radiofrequency Turbinate Reduction (Soft Tissue Only)

In cases where it is not necessary to revise the bone that underlies theturbinate, the surgeon may elect to perform a laser or radiofrequencyprocedure designed to create a coagulative lesion in (or on) theturbinate, which in turn causes the soft tissue of the turbinate toshrink. Also, in some cases, a plasma generator wand may be used createhigh energy plasma adjacent to the turbinate to cause a reduction in thesize of the turbinate.

One example of a radio frequency procedure that may be used to shrinkenlarged inferior turbinates is radiofrequency volumetric tissuereduction (RFVTR) using the Somnoplasty® system (Somnus MedicalTechnologies, Sunnyvale, Calif.). The Somnoplasty® system includes aradio frequency generator attached to a probe. The probe is insertedthrough the mucosa into the underlying soft tissue of the turbinate,usually under direct visualization. Radiofrequency energy is thendelivered to heat the submucosal tissue around the probe, therebycreating a submucosal coagulative lesion while allowing the mucosa toremain in tact. As the coagulative lesion heals, the submucosal tissueshrinks thereby reducing the overall size of the turbinate.Radiofrequency volumetric tissue reduction (RFVTR) can be performed asan office procedure with local anesthesia.

Many of the above-described procedures and techniques may be adaptableto minimally invasive approaches and/or the use of flexibleinstrumentation. There exists a need in the art for the development ofsuch minimally invasive procedures and techniques as well asinstrumentation (e.g., flexible instruments or catheters) useable toperform such procedures and techniques.

SUMMARY OF THE INVENTION

In general, the present invention provides methods, devices and systemsfor diagnosing and/or treating sinusitis or other conditions of the ear,nose or throat.

In accordance with the present invention, there are provided methodswherein one or more flexible catheters or other flexible elongatedevices as described herein are inserted in to the nose, nasopharynx,paranasal sinus, middle ear or associated anatomical passageways toperform an interventional or surgical procedure. Examples of proceduresthat may be performed using these flexible catheters or other flexibleelongate devices include but are not limited to: delivering contrastmedium; delivering a therapeutically effective amount of a therapeuticsubstance; implanting a stent, tissue remodeling device, substancedelivery implant or other therapeutic apparatus; cutting, ablating,debulking, cauterizing, heating, freezing, lasing, dilating or otherwisemodifying tissue such as nasal polyps, aberrant or enlarged tissue,abnormal tissue, etc.; grafting or implanting cells or tissue; reducing,setting, screwing, applying adhesive to, affixing, decompressing orotherwise treating a fracture; delivering a gene or gene therapypreparation; cutting, ablating, debulking, cauterizing, heating,freezing, lasing, forming an osteotomy or trephination in or otherwisemodifying bony or cartilaginous tissue within paranasal sinus orelsewhere within the nose; remodeling or changing the shape, size orconfiguration of a sinus ostium or other anatomical structure thataffects drainage from one or more paranasal sinuses; removing puss oraberrant matter from the paranasal sinus or elsewhere within the nose;scraping or otherwise removing cells that line the interior of aparanasal sinus; removing all or a portion of a tumor; removing a polyp;delivering histamine, an allergen or another substance that causessecretion of mucous by tissues within a paranasal sinus to permitassessment of drainage from the sinus; implanting a cochlear implant orindwelling hearing aid or amplification device, etc.

Further in accordance with the invention, there are provided methods fordiagnosing and assessing sinus conditions, including methods fordelivering contrast media into cavities, assessing mucosal flow,assessing passageway resistance and ciliary function, exposing certainregions to antigen challenge, etc

Still further in accordance with the invention, there are provided noveldevices for performing some or all of the procedures described herein.

Further aspects, details and embodiments of the present invention willbe understood by those of skill in the art upon reading the followingdetailed description of the invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A (Prior Art) is a frontal view of a human head showing thelocations of the paranasal sinuses.

FIG. 1B (Prior Art) is a side view of a human head showing the locationsof the paranasal sinuses.

FIG. 2A is a partial sectional view of head of a human patient showingthe right nasal cavity, the right side of the nasopharynx and theassociated paranasal sinuses, with an anterior/posterior occluder &access device of the present invention inserted therein.

FIG. 2B is a partial sectional view of head of a human patient showingthe left nasal cavity, the left side of the nasopharynx and theassociated paranasal sinuses, with an anterior occluder & access deviceof the present invention inserted therein.

FIG. 2C is a cross sectional view through line C-C of FIG. 2A.

FIG. 2D is a cross sectional view through line D-D of FIG. 2B.

FIG. 2E is a perspective view of a posterior occluder/suction/accessdevice of the present invention that is insertable through the oralcavity.

FIG. 2F is a cross-sectional view through Line 2F-2F of FIG. 2E.

FIG. 2G is a partial sectional view of head of a human patient showingthe right nasal cavity, the right side of the nasopharynx and theassociated paranasal sinuses, with an anterior occluder & access deviceof the present invention inserted in the right nasal cavity and aposterior occluder/suction/access device of FIG. 2E inserted through theoral cavity.

FIG. 2H is a partial sectional view of head of a human patient showingthe left nasal cavity, the left side of the nasopharynx and theassociated paranasal sinuses, with an anterior occluder & access deviceof the present invention inserted in the left nasal cavity and the sameposterior occluder/suction/access device that appears in FIG. 2Gextending through the oral cavity.

FIG. 2I is a perspective view of a posterior occluder/suction device ofthe present invention that is insertable transnasally.

FIG. 2J is a cross-sectional view through Line 2J-2J of FIG. 2I.

FIG. 2K is a partial sectional view of head of a human patient showingthe right nasal cavity, the right side of the nasopharynx and theassociated paranasal sinuses, with the posterior occluder/suction deviceshown in FIG. 21 inserted through the right nasal cavity.

FIG. 2L is a partial sectional view of head of a human patient showingthe left nasal cavity, the left side of the nasopharynx and theassociated paranasal sinuses and showing the posterior occluder portionof the device of FIG. 2K residing in and occluding the nasopharynx at alocation posterior to the septum and superior to the glottis.

FIG. 2M is a partial sectional view of head of a human patient showingthe right nasal cavity, the right side of the nasopharynx and theassociated paranasal sinuses, with an extended posterioroccluder/suction device inserted through the right nasal cavity.

FIG. 2N is a partial sectional view of head of a human patient showingthe left nasal cavity, the left side of the nasopharynx and theassociated paranasal sinuses and showing the posterior occluder anddistal tubular extension portions of the device of FIG. 2M residing inthe nasopharynx posterior to the septum and superior to the glottis.

FIG. 2O is a partial sectional view of head of a human patient showingthe right nasal cavity, the right side of the nasopharynx and theassociated paranasal sinuses, with a posterior occluder/slidable suctiondevice inserted through the right nasal cavity.

FIG. 2P is a partial sectional view of head of a human patient showingthe left nasal cavity, the left side of the nasopharynx and theassociated paranasal sinuses and showing the posterior occluder anddistal portion of the slidable suction cannula of the device of FIG. 2Oresiding in the nasopharynx posterior to the septum and superior to theglottis.

FIG. 2Q is a partial sectional view of head of a human patient showingthe right nasal cavity, the right side of the nasopharynx and theassociated paranasal sinuses, with another posterior occluder/taperedsuction device inserted through the right nasal cavity.

FIG. 2R is a partial sectional view of head of a human patient showingthe left nasal cavity, the left side of the nasopharynx and theassociated paranasal sinuses and showing the posterior occluder anddistal portion of the tapered suction cannula of the device of FIG. 2Qresiding in the nasopharynx posterior to the septum and superior to theglottis.

FIG. 3A is a partial perspective view of one embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIG. 3B is a partial perspective view of another embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIG. 3C is a partial perspective view of another embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIG. 3C′ is a cross sectional view through line 3C′-3C′ of FIG. 3C.

FIG. 3D is a partial perspective view of yet another embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIG. 3E′, 3E″ and 3E′″ are partial perspective views of still anotherembodiment of an occluder/suction device of the present inventionshowing various steps in a process by which the occluder/suction deviceis positioned within an anatomical passageway.

FIG. 3F is a partial perspective view of still another embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIGS. 3F′, 3F″ and 3F′″ show alternative constructions of the distalportion of the suction cannula of the occluder/suction device shown inFIG. 3F.

FIG. 3G is a partial perspective view of still another embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIG. 3H is a partial perspective view of still another embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIG. 3I is a partial perspective view of still another embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIG. 3J is a partial perspective view of still another embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIG. 3K is a partial perspective view of still another embodiment of anoccluder/suction device of the present invention positioned within ananatomical passageway.

FIGS. 3L′ and 3L″ show partial longitudinal sectional views of anotheroccluder/suction device of the present invention.

FIGS. 3M′ and 3M″ show partial perspective views of anotheroccluder/suction device of the present invention positioned within ananatomical passageway.

FIG. 4 is a longitudinal sectional view of the oropharynx and anteriorneck of a human patient having a nasopharyngeal occluder/endotrachealtube device of the present invention inserted through the right nasalcavity and into the trachea.

FIG. 5A is a partial perspective view of a side cutting or ablationdevice being used in accordance with the present invention.

FIG. 5B is a partial perspective view of a device having laterallydeployable needles, electrodes or other treatment deliveringprojections, being used in accordance with the present invention.

FIG. 5C is a partial perspective view of a drill (e.g., a tissue drill,bone drill, or trephine device) being used in accordance with thepresent invention.

FIG. 5D is a partial perspective view of a catheter having a laterallydeployed needle or tube for delivering a substance or apparatus to atarget location and an optional on-board imaging or guidance apparatus,being used in accordance with the present invention.

FIG. 5E is a partial perspective view of a balloon catheter being usedin accordance with the present invention.

FIG. 5F is a partial perspective view of a balloon catheter havingblades or electrodes thereon, being used in accordance with the presentinvention.

FIG. 5G′ is a partial perspective view of a balloon catheter having astent positioned thereon being inserted into an occluded region withinthe nose, nasopharynx or paranasal sinus in accordance with the presentinvention.

FIG. 5G″ shows the balloon catheter and stent of FIG. 3G′, with theballoon inflated and the stent expanded so as to open or dilate theoccluded region within the nose, nasopharynx or paranasal sinus.

FIG. 5G′″ shows the balloon catheter and stent of FIG. 3G′ with thestent implanted, the balloon deflated and the catheter being withdrawnand removed.

FIG. 5H is a partial perspective view of a tissue shrinking electrodedevice being used in accordance with the present invention.

FIG. 5I is a partial perspective view of a cryogenic or plasma statetreatment device being used in accordance with the present invention.

FIG. 5J is a partial perspective view of an expandable tissue expandingdevice positioned within a passageway in the nose, nasopharynx orparanasal sinus in accordance with the present invention.

FIG. 5K is a partial sectional view of one embodiment of a forwardcutting/suction catheter of the present invention.

FIG. 5K′ shows the device of FIG. 5K being used to remove a nasal polypor other obstructive mass from an anatomical passage within the nose orparanasal sinus.

FIG. 5L is a partial sectional view of a forward cutting/suctioncatheter/endoscope device of the present invention.

FIG. 5M is a partial sectional view of a side cutting/suction catheterdevice of the present invention.

FIG. 5N is a partial sectional view of a side cutting/suction catheterdevice of the present invention having an optional guidewire lumen andoptional endoscopic component(s).

FIG. 5O is a partial perspective view of the distal end of a guidecatheter/endoscope of the present invention.

FIG. 5P is a partial perspective view of a ballooncatheter/pressure-expandable intranasal stent/endoscope device of thepresent invention.

FIG. 5Q is a partial perspective view of a delivery catheter/selfexpanding intranasal stent/endoscope device of the present invention.

FIG. 5Q′ is a cross-sectional view through line 5Q′-5Q′ of FIG. 5Q.

FIG. 5R′ shows an example of an optional modified shape of the balloonand stent of FIG. 5P.

FIG. 5R″ shows another example of an optional modified shape of theballoon and stent of FIG. 5P.

FIG. 5S is a partial perspective view of a snare catheter of the presentinvention with optional endoscopic component(s).

FIG. 5T is a partial perspective view of a forceps device of the presentinvention having optional endoscopic component(s).

FIG. 5U is a partial perspective view of a system of the presentinvention comprising a guide catheter, endoscope and guidewire.

FIG. 5U′ is a cross-sectional view through line 5T′-5T′ of FIG. 5T.

FIG. 5V is a partial perspective view of a microdebrider catheter of thepresent invention.

FIG. 5W is a partial perspective view of a bone remodeling device of thepresent invention.

FIGS. 5W′ and 5W″ show steps in a method for using the bone remodelingdevice of FIG. 5W.

FIGS. 5X′-5X″″ are partial perspective views of alternative designs forbone remodeling devices of the present invention.

FIGS. 5Y-5Y are perspective views of examples of substance deliveringimplant devices useable in the present invention.

FIG. 6A is a perspective view of one embodiment of a sphenoid sinusguide catheter of the present invention.

FIG. 6B is a perspective view of a frontal sinus guide catheter of thepresent invention.

FIG. 6C is a perspective view of one embodiment of a maxillary sinusguide catheter of the present invention.

FIG. 6D is a perspective view of one embodiment of an ethmoid sinusguide catheter of the present invention.

FIG. 6E is a perspective view of one embodiment of a plugging guidecatheter of the present invention useable for temporarily plugging theopening into a nasolacrimal duct or Eustachian tube.

FIG. 7A is a sectional view of a paranasal sinus with a catheterintroducing an expandable electrode cage into the sinus in accordancewith the present invention.

FIG. 7B is a sectional view of a paranasal sinus that is filled with adiagnostic or therapeutic substance and wherein a plug tipped catheteris being used to plug the ostium of the sinus to retain the substancewithin the sinus, in accordance with the present invention.

FIG. 7C is a sectional view of a paranasal sinus with a catheterintroducing a diagnostic or therapeutic substance into contact with thetissue lining the sinus, in accordance with the present invention.

FIG. 7D is a sectional view of a paranasal sinus with a catheter havingemitters and/or sensors for 3 dimensional mapping or navigation, inaccordance with the present invention.

FIG. 7E is a sectional view of a paranasal sinus with a catheterdelivering a coil apparatus into the sinus to embolize the sinus and/orto deliver a diagnostic or therapeutic substance into the sinus inaccordance with the present invention.

FIG. 7F is a sectional view of a paranasal sinus with a guide catheter,guide wire and over-the-wire flexible endoscope inserted into the sinus,in accordance with the present invention.

FIG. 7G shows the guide catheter and endoscope of FIG. 5F with a workingdevice (e.g., a biopsy instrument) inserted through a working channel ofthe endoscope to perform a procedure within the sinus under endoscopicvisualization, in accordance with the present invention.

FIGS. 8A-8E show steps in a sinus treatment procedure conducted inaccordance with the present invention.

FIGS. 9A-9C show steps in a cochlear implant procedure conducted inaccordance with the present invention.

DETAILED DESCRIPTION

The following detailed description and the accompanying drawings areintended to describe some, but not necessarily all, examples orembodiments of the invention only and does not limit the scope of theinvention in any way.

A number of the drawings in this patent application show anatomicalstructures of the ear, nose and throat. In general, these anatomicalstructures are labeled with the following reference letters:

-   -   Nasal Cavity NC    -   Nasopharynx NP    -   Superior Turbinate ST    -   Middle Turbinate MT    -   Inferior Turbinate IT    -   Frontal Sinus FS    -   Ethmoid Sinus ES    -   Sphenoid Sinus SS    -   Sphenoid Sinus Ostium SSO    -   Maxillary Sinus MS

The human nose has right and left nostrils or nares which lead intoseparate right and left nasal cavities. The right and left nasalcavities are separated by the intranasal septum, which is formedsubstantially of cartilage and bone. Posterior to the intranasal septum,the nasal cavities converge into a single nasopharyngeal cavity. Theright and left Eustachian tubes (i.e., auditory tubes) extend from themiddle ear on each side of the head to openings located on the lateralaspects of the nasopharynx. The nasopharynx extends inferiorly over theuvula and into the pharynx. As shown in FIGS. 1A and 1B, paranasalsinuses are formed in the facial bones on either side of the face. Theparanasal sinuses open, through individual openings or ostia, into thenasal cavities. The paranasal sinuses include frontal sinuses FS,ethmoid sinuses ES, sphenoidal sinuses SS and maxillary sinuses MS.

The present invention provides a comprehensive system of devices andassociated methods for diagnosing and treating disorders of the ears,nose and throat in a less invasive fashion than current day approaches.Specifically, examples of which are described below, the inventionprovides devices that wholly or partially effect a fluid-tight seal ofthe operative field (e.g., the nasopharynx and/or one or more of thesinus cavities or regional ducts). This fluid-tight sealing of theoperative field allows the cavities, ducts and passageways to be imagedusing fluid/gas based agents in combination with various imagingmodalities without the risk of aspiration or uncontrolled leakage offluid from the operative field. Further, this fluid-tight sealing of theoperative field permits the retention and collection of any blood orflushing fluids released during the procedure. Another aspect of theinvention is a set of methods and devices useable to assess the staticand dynamic nature of the paranasal sinuses and to provide for theguidance of specific therapies to particular sinuses or particulartarget regions (e.g., stenotic sinus ostia, infected tissues withinsinuses, tumors, other target structures). Another aspect of theinvention is the use of devices and methods which are designed forminimally invasive entry into the sinus passageways or regional ductsunder image and/or endoscopic guidance to provide local therapy such asdilation, ablation, resection, injection, implantation, etc. to theregion of concern. These devices and methods may be disposable ortemporary in their application, or they may be implantable with on-goingfunctionality (such as implantable drug delivery systems, cochlearimplants, etc.). In a number of embodiments, the present inventionutilizes flexible catheters and various working devices that are mountedon or delivered through elongate flexible members or catheters, todiagnose and treat a wide range or ear, nose and throat disordersincluding; nasal polyps, sinusitis, enlarged turbinates, deviatedseptum, tumors, infections, deformities, etc. The following pagesdescribe a number of specific devices and methods that are useable inaccordance with this invention. It is to be understood that anycomponent, element, limitation, attribute or step described in relationto any particular device or method described herebelow, may beincorporated in or used with any other device or method of the presentinvention unless to do so would render the resultant device or methodunusable for its intended purpose.

Occluders & Access Port Devices

Many of the procedures of the present invention require the insertionand positioning of one or more flexible catheters or other flexibleelongate working devices (examples of which are shown in FIGS. 5A-5Y anddescribed herebelow) within the nose, nasopharynx, middle ear orparanasal sinuses. To facilitate the insertion and proper positioning ofsuch catheters and/or other elongate working devices and to preventundesirable drainage of blood or debris from the operative site, thepresent invention includes a number of different occluder and/or accessport devices, examples of which are shown in FIGS. 2A-2R, that areinserted through the nose and/or oral cavity and function to a) preventunwanted drainage or escape of fluid (e.g., gas or liquid) and b)facilitate the insertion and positioning of guides and working devices,examples of such working devices being shown in FIGS. 5A-5Y′″″ and6A-6E.

FIGS. 2A-2B show partial sectional views of opposite sides of the headof a human patient having an anterior/posterior occluder & access device10 inserted through the right nasal cavity and anterior occluder &access device 12 positioned in the anterior region of the left nasalcavity. Specifically, FIG. 2A shows the nasal cavity, the right side ofthe nasopharynx and the associated paranasal sinuses, with ananterior/posterior occluder & access device 10 of the present inventioninserted therein. The anterior/posterior occluder & access device 10comprises an anterior occluder 14 which occludes the right nasal cavityon the right side of the nasal septum, a posterior occluder 18 thatoccludes the posterior choanae, nasopharynx or pharynx posterior to thenasal septum (but typically superior to the glottis) and a tube 16 thatextends between the anterior occluder 14 and posterior occluder 18.Devices for posterior occlusion and anterior occlusion may be used aloneor in combination. They may be coaxially deployed or alternatively theymay be deployed in a singular fashion, one in each orifice. It should benoted that any combination of these sealing modalities may be employedto achieve one or more of the stated objectives. A cross-section throughthe tube 16 is shown in FIG. 2C. Other cross-sectional configurationscould also be possible, including those that comprise more lumens topermit the passage of multiple devices or fluids (e.g., liquid orgases). In some embodiments, it may be desirable for the device 10 (orany of the other occluder/access devices described herein) to haveseparate lumens for infusion and aspiration, thereby allowing forconcurrent infusion of an irrigation fluid or other fluid and suctioningof the irrigation fluid or other fluid from the operative field. Suchcontinuous turnover of fluid within a sealed operative field may beuseful for clearing blood or debris from the operative field tofacilitate unobstructed viewing of the anatomical structures using anendoscope or for various other reasons. A port body 28 as attached tothe proximal end of the tube 16. A device insertion aperture 30 extendsthrough the port body 28 into working lumen 50 of tube 16. One or moreoutlet openings 22, 24 are at location(s) in the tube such that a device(e.g., a catheter, fluid injector or other elongate device examples ofwhich are shown in FIGS. 5A-5Y″″ and described herebelow) or fluid(s)may be inserted into the device insertion opening 30, advanced throughthe working lumen 50 and out of a selected one of the outlet openings22, 24 to a position within the nose, nasopharynx or paranasal sinus. Inthe particular embodiment shown in FIG. 2A the anterior and posterioroccluders 14, 18 comprise balloons, but various other types of occluderscould be used in place of balloons, examples of which are shown in FIGS.3A-3K and described herebelow. Balloon inflation/deflation lumens 52, 56extends from proximal Luer connectors 32, 36, through the tube 16 and tothe anterior occluder 14 and posterior occluder 18, respectively. Thus,a syringe or other fluid expelling and/or withdrawing device may beconnected to connector 32 and used to selectively inflate and/or deflatethe anterior occluder 14. Another syringe or other fluid expellingand/or withdrawing device may be connected to connector 36 and used toselectively inflate and/or deflate the posterior occluder 18. As may beappreciated from the showing of FIG. 2B, the posterior occluder (whenfully inflated) may be sized and shaped to occlude the entire posteriorchoanae, nasopharynx or pharynx posterior to the nasal septum (buttypically superior to the glottis), thereby preventing blood or otherfluid or debris from draining into the patient's pharynx from either theright or left nasal cavity. When fully inflated, the anterior occluder14 of the device 10 occludes only the right nasal cavity and serves toprevent blood, other fluid or debris from draining around the tube 16and out of the right nostril during the operative procedure. A one wayvalve, such as a flapper valve, duckbill valve, hemostatic valve orother one way valve of the type well known in the art of biomedicaldevice design, may be positioned within the port body 28 to permit acatheter or other elongate device (examples of which are shown in FIGS.5A-5T and described herebelow) to be advanced in the distal directionthough insertion port 30, through the port body 28 and through theworking lumen 50 but to prevent blood, other fluid or debris fromdraining through the working lumen 50 out of the device insertion port30. In this manner, the device 10 forms a substantially fluid tightanterior seal in the anterior aspect of the right nasal cavity and asubstantially fluid tight posterior seal in the posterior choanae,nasopharynx or pharynx posterior to the nasal septum (but typicallysuperior to the glottis). Since a substantially fluid tight seal isformed, one or more valves (not shown) may be provided to relievepositive or negative pressure created between the anterior or posterioroccluders 14, 18 as a result of the injection of matter (e.g., contrastmedium, irrigation solution, medicament, etc.) into the operative fieldand/or suctioning or removal of matter (e.g., blood, other fluid ordebris) from the operative field. Additionally, a suction lumen 54 mayextend from suction Luer connector 34, through suction lumen 54 and tosuction openings 26 may be formed in the tube 16. A suction pump may beconnected to the suction connector 34 to aspirate blood, other fluidand/or debris out of the right nasal operative region defined betweenanterior occluder 14 and posterior occluder 18. It should be appreciatedthat, while the occlusion/access devices shown in the drawings anddescribed herein are designed to isolate a relatively large operativefield (e.g., one or both nasal cavities, sinus, nasalcavities-nasopharynx, etc.), once a specific problem has been diagnosedand/or once a specific target region has been identified, the occluders14, 18 may be repositioned and/or other occluder devices may be insertedto isolate and form a fluid tight seal of just a portion of the originaloperative field (e.g., just one sinus, one nasal cavity, one Eustachiantube, etc.) thereby allowing the procedure to go forward with only thenecessary region(s) of the nose, nasopharynx, paranasal sinuses or otherstructures sealed off and/or instrumented, to minimize trauma andimprove patient comfort.

It should be appreciated that in any embodiment of an anterior/posterioroccluder & access device, such as the device 10 shown in FIGS. 2A and2B, the distance between the anterior occluder 14 and posterior occluder18 may be adjustable so as to accommodate variations in anatomy and/orspecific target regions or isolated operative fields of interest. Theanterior and posterior occluders 14, 18 may be separate devices wherethe anterior occluder may slide or pass through one lumen of theposterior occluder, which may contain several lumens (e.g., inflation,working channel, irrigation, etc.), and may or may not be integratedwith the posterior occluder. The posterior occluder may also containseveral lumens (e.g., inflation, working channel, irrigation, etc.).Additionally, all lumens for both the anterior and posterior occludersmay contain valves so as to prevent leakage or flow of gas, fluid,blood, etc.

It is to be further appreciated that in embodiments that have anteriorand posterior outlet openings 22, 24 (as shown in the example of FIGS.2A-2B) tools, instrumentation and fluids may be delivered via either ofthe posterior or anterior access ports 22, 24. In some cases, access viaa posterior outlet 24 is desirable to gain a better perspective on thetarget anatomical lumen or lumen (i.e. openings to the ethmoid cells).

As shown in FIGS. 2B and 2D, in some procedures wherein theanterior/posterior occluder & access device 10 is inserted through onenasal cavity, it may be desirable to position a separate anterioroccluder & access device 12 within the opposite nasal cavity to preventdrainage of blood, other fluid or debris from the other nostril and tofacilitate insertion of catheters or other elongate devices (examples ofwhich are shown in FIGS. 5A-5T and described herebelow) into the leftnasal cavity and the paranasal sinuses or other anatomical structuresaccessible from the other nasal cavity. As shown, in FIG. 2B, theanterior occluder & access device 12 may comprise a tube 41 having ananterior occluder 40 and a port body 42 attached thereto. A deviceinsertion aperture 44 extends through the port body 42 and through aworking lumen 58 of tube 41 to an outlet aperture in the distal end oftube 41. A one way valve (such as the valve described hereabove inconnection with the anterior/posterior occluder & access device 10) mayoptionally be provided within port body 42 to prevent draining of blood,other fluid or debris out of insertion aperture 44. In the particularembodiment shown in FIGS. 2B and 2D, the anterior occluder 40 is aballoon, but such occluder 40 may be of various other constructions,examples of which are shown in FIGS. 3A-3M″ and described herebelow. Tofacilitate inflation and deflation of this balloon type anterioroccluder 40, a balloon inflation/deflation lumen 60 extends from Luerconnector 48, through tube 41 to the balloon-type anterior occluder 40.A syringe or other fluid expelling and/or withdrawing device may beconnected to connector 48 and used to selectively inflate and/or deflatethe anterior occluder 40. Optionally, a side tube and Luer connector 46may be connected to the working lumen 58 of tube 41 to allow blood,other fluid and debris to be suctioned from the left nasal cavitythrough the working lumen 58 of tube 41. In some embodiments, dedicatedsuction and/or irrigation lumen(s) with separate suction and/orirrigation ports may be formed in tube 41 in a manner similar to thatdescribed hereabove with respect to the anterior/posterior occluder &access device 10.

FIGS. 2E-2H show an alternative system for occlusion and access, whereinanterior occluder & access device(s) 12 is/are positioned in one or bothnostrils or nasal cavities and an orally insertable posterior occluderdevice 300 is inserted through the patient's oral cavity and positionedso as to occlude the posterior choanae, nasopharynx or pharynx posteriorto the nasal septum (but typically superior to the glottis). Theembodiment of the orally insertable posterior occluder device 300 shownin FIGS. 2E-2G comprises a curved tube 302 having an occluder 304positioned at or near the distal end thereof. The device 300 isconfigured such that it may be inserted through the patient's oralcavity to a position where the occluder 304 is located within, anddisposed, so as to substantially occlude the posterior choanae,nasopharynx or pharynx posterior to the nasal septum (but typicallysuperior to the glottis). The posterior occluder 304 may also bepositioned next to the Eustachian tube to block the Eustachian tube,thereby preventing fluid from tracking into the Eustachian tube duringthe procedure (if access to the Eustachian tube or middle ear or innerear is not desired). Further, it may be necessary to place specifictargeted balloons or occluders in ducts or channels which are notintended to be intervened upon (lacrimal ducts, Eustachian tubes, etc.).In such cases, these extra ductal occluders serve to prevent aberrantfluid/gas loss and/or to maintain the integrity of the lumen, whileother nearby structures are being modified. In the particular exampleshown in FIGS. 2E-2G, the occluder 304 comprises a balloon. However,such occluder 304 may be constructed in various alternative ways,examples of which are shown in FIGS. 3A-3K and described herebelow. Asmay be appreciated from the cross-sectional showing of FIG. 2F, in thisexample a balloon inflation/deflation lumen 318 may extend from Luerconnector 314, through tube 302 to the balloon-type occluder 304. Asyringe or other inflation/deflation apparatus may be attached to theLuer connector 314 and used to inflate and deflate the balloon 304. Astopcock or other valve (not shown) may also be provided on ballooninflation tube 318 to maintain inflation of the balloon when desired. Inroutine use, the occluder 304 is initially deflated and the device 300is inserted through the oral cavity and advanced to its desired positionwith the deflated occluder positioned within the posterior choanae,nasopharynx or pharynx posterior to the nasal septum (but typicallysuperior to the glottis). Thereafter, the occluder 304 may be expanded(e.g., inflated) such that it occludes or blocks the posterior choanae,nasopharynx or pharynx posterior to the nasal septum (but typicallysuperior to the glottis), thereby substantially preventing blood, otherfluid or debris from draining into the patient's esophagus or tracheaduring the procedure. In some cases, as shown in FIGS. 2E-2H, the tube302 may have one or more lumen(s) 310 that extend(s) through theoccluder 304 and open(s) through an opening 310 distal to the balloon.Working devices, such as catheters or other elongate devices examples ofwhich are shown in FIGS. 5A-5Y′″″ and described herebelow may beadvanced through such a lumen 310 and into the patient's nasopharynx,nasal cavities, paranasal sinuses, middle ears, etc. Alternatively,suction may be applied to such a lumen 310 to suction blood, other fluidor debris from the area superior to the occluder 304. In some cases, thelumen 310 shown may be divided into a working lumen and a suction lumen.The suction lumen may terminate in separate suction port(s) (not shown)at the distal end of the tube and a connector (not shown) at theproximal end, such that suction may be applied through a lumen that isseparate from the lumen through which the working device(s) is/arepassed. A port body 306 may be positioned on the proximal end of thetube 302. A device insertion port 308 may extend through the port body306 into a lumen 310 of the tube 302. A one way valve, such as a flappervalve, duckbill valve, hemostatic valve or other one way valve of thetype well known in the art of biomedical device design, may bepositioned within the port body 306 to permit a catheter or otherelongate device to be advanced in the distal direction though insertionport 308, through the port body 306 and through a lumen 310 but toprevent blood, other fluid or debris from draining through the lumen 310and out of the device insertion port 308. In some cases, the orallyinsertable posterior occluder device 300 may be used without anyanterior occluder device(s) positioned in the nostril(s) or nasalcavity(ies). In other cases, it will be desirable to use this orallyinsertable posterior occluder device 300 in combination with one or twoanterior occluder & access devices 12 as shown in the example of FIGS.2G and 2H. The use of these devices 300, 12 in combination serves toestablish a substantially fluid tight operative field between theposterior occluder 304 and the anterior occluder(s) 40 while allowingvarious catheters and other operative instruments to be inserted intothe operative field through optional access ports 44 and/or 308.

FIGS. 2I-2L show a trans-nasally insertable posterior occluder device301 that does not include any anterior occluder. This device 301comprises a curved tube 303 having an occluder 305 positioned at or nearthe distal end of the tube 303. As shown in FIGS. 2K-2L, this device 301is inserted through either the right or left nasal cavity and advancedto a position where the occluder 305 substantially occludes theposterior choanae, nasopharynx or pharynx posterior to the nasal septum(but typically superior to the glottis). In the particular exampleshown, this occluder 305 comprises a balloon. However, such occluder 305may be constructed in various alternative ways, examples of which areshown in FIGS. 3A-3K and described herebelow. As may be appreciated fromthe cross-sectional showing of FIG. 2J, in this example a ballooninflation/deflation lumen 317 may extend from Luer connector 311,through tube 303 to the balloon-type occluder 305. A syringe or otherinflation/deflation apparatus may be attached to the Luer connector 311and used to inflate and deflate the balloon-type occluder 305. Astopcock or other valve (not shown) may also be provided on ballooninflation lumen 317 to maintain inflation of the balloon when desired.In routine use, the occluder 305 is initially deflated and the device301 is inserted through the right or left nasal cavity and advanced toits desired position where the deflated occluder 305 is positionedwithin the posterior choanae, nasopharynx or pharynx posterior to thenasal septum (but typically superior to the glottis). Thereafter, theoccluder 305 may be expanded (e.g., inflated) such that it occludes orblocks the posterior choanae, nasopharynx or pharynx posterior to thenasal septum (but typically superior to the glottis), therebysubstantially preventing blood, other fluid or debris from draining intothe patient's esophagus or trachea during the procedure. Optionally,distal suction ports 309 and/or proximal suction ports 307 may open intolumen 315 of the tube 303 and such lumen 315 may be attached to asuction connector 313. In this manner, suction may be applied to removeblood, other fluid or debris from the nasopharynx superior to theoccluder 305 and/or from the nasal cavity through which the device 3301is inserted. As may be appreciated from the showings of FIGS. 2K and 2L,in this example, the trans-nasal posterior occluder device 301 isinserted through the right nasal cavity. A working device WD such as acatheter or other elongate operative apparatus (examples of which areshown in FIGS. 5A-5Y and described herebelow) may be advanced into theright nasal cavity adjacent to the tube 303 or through the left nasalcavity which remains open, as no anterior occlusion is provided by thistrans-nasal posterior occluder device 301. This arrangement may beparticularly suitable for procedures where the physician desires todirectly visualize, through the nostril(s), the anatomical structureswithin the nose, such as the inferior, middle or superior turbinates IT,MT, ST, as shown in FIGS. 2K-2L.

FIGS. 2M-2N show a modified version of the trans-nasal posterioroccluder 301 a which includes all of the elements described above withrespect to the trans-nasal posterior occluder device 301 shown in FIGS.2I-2L as well as a distal extension 303 a of the tube 303 that extendsdistal to the occluder 305 and an additional proximal connector 319. Aseparate lumen (not shown) extends from connector 319 through tube 303and through distal tube extension 303 a, which terminates in a distalend opening 321. Suction may thus be applied to connector 319 to suctionmatter through distal opening 321, through the distal tube extension 303a and through tube 303. This distal tube extension 303 a and additionallumen may be optionally added to any other the other posterior occluderdevices described herein in cases where doing so would not render thedevice unsuitable for its intended application.

FIGS. 2O-2P show an alternative posterior occluder system 400 thatcomprises an intranasal catheter 402 that is inserted into a nasalcavity and an occluder catheter 404 that is inserted through theintranasal catheter 402, as shown. A posterior occluder 406 is locatedat or near the distal end of the occluder catheter 404. In theparticular embodiment shown in FIGS. 2O-2P, the occluder 406 is sizedand configured to occlude the posterior choanae, nasopharynx or pharynxposterior to the nasal septum (but typically superior to the glottis).In the particular example shown, this occluder 406 comprises a balloon.However, such occluder 406 may be constructed in various alternativeways, examples of which are shown in FIGS. 3A-3K and describedherebelow. In this example a balloon inflation/deflation lumen mayextend from Luer connector 408, through occluder catheter 404 and to theballoon-type proximal occluder 406. A syringe or otherinflation/deflation apparatus may be attached to the Luer connector 408and used to inflate and deflate the balloon-type posterior occluder 406.A stopcock or other valve (not shown) may also be provided on theballoon inflation/deflation lumen to maintain inflation of theballoon-type posterior occluder 406, when desired. Optionally, distaltubular extension 412 may extend distally of the posterior occluder 406and a separate lumen may extend from an optional second connector 410,through distal tubular extension 412 and through an opening 414 suchthat matter may also be aspirated from the area distal to the posterioroccluder 406. A port body 418 is formed on the proximal end of theintranasal tube 402. An insertion port 420 extends through port body 418into the lumen 422 of the intra nasal tube. A side suction port 416 mayalso be connected to the lumen 422 of the intranasal tube 402. Inroutine operation, the intranasal tube 402 is inserted through thenostril into one nasal cavity and advanced to a position where itsdistal end is within or near the posterior choanae or nasopharynx. Withthe posterior occluder 406 in a collapsed (e.g., deflated)configuration, the occluder catheter 404 is advanced through the lumen422 of the intranasal catheter 402 to a position where the posterioroccluder is located in the posterior choanae, nasopharynx or pharynxposterior to the nasal septum (but typically superior to the glottis).Thereafter, the posterior occluder 406 may be expanded (e.g., inflated)such that it occludes or blocks the posterior choanae, nasopharynx orpharynx posterior to the nasal septum (but typically superior to theglottis), thereby substantially preventing blood, other fluid or debrisfrom draining into the patient's esophagus or trachea during theprocedure. Thereafter, suction may be applied to suction port 416 tosuction blood, other fluid or debris from the area proximal to theposterior occluder 406. During such suctioning, the intranasal tube 402may be moved back and/or forth as indicated by arrows on FIG. 2O, whilethe occluder catheter 404 remains stationary. Such ability to move theintranasal catheter 402 during the suctioning process may facilitatecomplete removal of blood, other fluid and/or debris from the operativefield.

FIGS. 2Q and 2R show a modified posterior occluder system 430 whichincludes the same elements and components as the posterior occludersystem 400 described above, but wherein the distal end 434 of theintranasal tube 402 a is tapered and wherein a plurality of sideapertures 432 are formed in the intranasal tube 402 a such that blood,other fluid or debris may be aspirated into the lumen 422 a of theintranasal tube 402 a through such side apertures 432.

B. Variations in Occluder Design and Suction Apparatus:

Although the above-described examples of occluder/access devices 10, 12,300, 400 show occluders that are in nature of inflatable balloons, itwill be appreciated that these occluders are not limited to balloons andmay be of various other designs and types. Further, it is to beunderstood that various arrangements of access and/or suctiontubing/port(s) may be used to facilitate complete removal of blood,fluid or other debris from the areas adjacent to the occluder(s) and/orelsewhere in the operative field or optimal positioning of workingdevices within the operative field. In fact, certain occluder and/orsuction-access tubing/port designs may be more desirable for certainprocedures than others depending on a number of factors including thepositioning of the patient's head during surgery, whether the patientwill be under a general anesthetic, whether an endotracheal tube will beinserted, etc. In some cases, where a posterior occluder is positionedwithin the posterior choanae, nasopharynx or pharynx posterior to thenasal septum the completeness with which blood, other fluid or debrismay be suctioned out of the area adjacent to that posterior occluder maydepend on the shape and/or design of the occluder itself as well as theshape and location of the suction lumen(s) and port(s) through which theblood, fluid or debris is to be suctioned. Beyond optimized fluidcontrol, the posterior occluder and/or associated access tubing may alsoserve as an essential guiding element for devices, and alternativeshapes and trajectories may be particularly useful to access specificstructures. FIGS. 3A-3K show examples of varied occluder types andvariations in the arrangements of suction lumen(s) and port(s) throughwhich the blood, fluid or debris may be suctioned from areas adjacent tothe occluder or elsewhere within the operative field. The examples shownin FIGS. 3A and 3K may be incorporated into the occluder & accessdevices shown in FIGS. 2A-2R, when appropriate.

FIG. 3A shows an occluder 446 mounted on a tube 442, wherein a generally“U” shaped curve is formed in the distal end of the tube such that adistal portion of the tube 442 passes beneath the upper surface 449 ofthe occluder 446 and curves upwardly such that the distal end of thetube 442 terminates in an opening 444 that is flush with the uppersurface 449 of occluder 446. In this manner, any fluid that hasaccumulated adjacent to the upper surface 449 of occluder 446 may besuctioned into opening 444 and through tube 442. In embodiments wherethe occluder comprises a balloon, a balloon inflation lumen may extendthrough the tube and open through an opening 447 into the interior ofthe balloon, to permit inflation/deflation of the balloon. Optionally, aworking device 448, such as a flexible catheter or elongate apparatusexamples of which are shown in FIGS. 5A-5T and described herebelow, mayalso be advanced through the suction lumen of tube 442 and out ofopening 444 as indicated on FIG. 3A.

FIG. 3B shows another alternative wherein an occluder 450 has adepression or well 454 formed in its upper surface. A tube 452 isattached to the occluder by attachment members 456 and the distal end ofthe tube 452 protrudes into well 454 such that any blood, fluid ordebris that collects within the well 454 may be suctioned through thetube 452. In embodiments where the occluder 450 comprises a balloon, thetube 452 may incorporate a balloon inflation/deflation lumen which mayextend through an inflation/deflation side tube 458 into the interior ofthe balloon to facilitate inflation and deflation of the balloon.

FIGS. 3C and 3C′ show another alternative wherein an occluder 460 had adepression or well 462 formed in its upper surface and a tube 464 isattached to the occluder 460, as shown. A lumen of the tube 464 is incommunication with the area adjacent the floor of the well to facilitatesuctioning of blood, fluid or debris that collects within the well. Inembodiments where the occluder 460 comprises a balloon, the tube 464 mayincorporate a suction lumen 468 and a balloon inflation/deflation lumen470. A small curved (e.g., generally “U” shaped) suction tube 466 may beconnected in a sealed connection to the distal end of suction lumen 468and the interior of the well 462 such that blood, other fluid or debrismay be suctioned from the well 462, through suction tube 466 and throughsuction lumen 468.

FIG. 3D shows a concave occluder 471 that comprises a self expandingconcave structure 472 such as a basket formed of a superelastic orresilient mesh material (e.g., nickel titanium alloy wire mesh). Theexpanding concave structure 472 is covered by a fluid impermeableflexible covering 474 such as a skin formed of flexible polymer (e.g.,expanded polytetrafluoroethylene, polyurethane, polyethyleneteraphthalate, etc.). When fully expanded the concave occluder 471occludes the body lumen in which it is positioned (e.g., the nasalcavity, posterior choanae, nasopharynx, pharynx, etc.) and forms aconcave well 479. A tube 480 extends into the well 479 of the concaveoccluder 471 and may be used to suction blood, fluid or debris from thewell 479. The occluder 471 may be advanced from and withdrawn into adelivery catheter 478. Struts 472 may connect the concave occluder 471to a delivery member (not shown) within the delivery catheter 478, suchdelivery member being advanceable to push the occluder 471 out of thedelivery catheter 478 and retractable to withdraw the occluder 471 intothe delivery catheter 478. When inside the delivery catheter, theoccluder 471 may be in a collapsed configuration but when expelled outof the delivery catheter the occluder will resiliently spring orself-expand to its expanded concave configuration, as shown in FIG. 3D.The suction catheter 480 may advance from and/or retract into thedelivery catheter 478 concurrently with, or separately from, theoccluder 471.

FIGS. 3E′-3E′″ show yet another occluder/suction arrangement wherein theoccluder 484 comprises an everting tubular member that is advanceablefrom a delivery/suction catheter 486. The everting tubular membercomprises a frame 488 that is covered with a covering 500. Initially theeverting tubular member is in a substantially cylindrical configurationwithin the lumen of the delivery/suction catheter 486. The frame may bea resilient or superelastic material that is biased to the everted shapeshown in FIG. 3E′″. Such frame 488 may be formed of mesh material (e.g.,nickel titanium alloy wire mesh). The covering 500 may be formed offlexible polymer (e.g., expanded polytetrafluoroethylene, polyurethane,polyethylene teraphthalate, etc.) In operation, the delivery/suctioncatheter 486 is advanced to the position where it is desired to placethe occluder 484. Then, the everting tube is advanced from the distalend opening of the delivery/suction tube 486, as shown in FIGS. 3E′ and3E″. As it advances out of the catheter 486, the everting tube memberassumes its everted configuration, forming a concave occluder 484 asshown in FIG. 3E′″. The occluder 484, when fully everted, occludes thebody lumen in which it is positioned (e.g., the nasal cavity, posteriorchoanae, nasopharynx, pharynx, etc.) and creates a concave well 504. Thedelivery/suction catheter 486 may be advanced into the concave well 504such that any blood, fluid or debris that collects within concave well504 may be suctioned through suction ports 502 and through the distalend of the delivery/suction catheter 486.

FIG. 3F-3F′″ show another embodiment wherein an occluder 510 ispositioned on the end of a tube 512. The occluder 510 has an archedupper surface such that a generally “V” shaped annular collection space518 is created in the region of the coaptation between the occluder 510and the adjacent wall of the body lumen in which it is positioned (e.g.,a nasal cavity, posterior choanae, nasopharynx, pharynx, etc.). Asuction tube 516 extends from tube 512 into the annular collection space518 and blood, other fluid or debris that collects in the annularcollection space 518 may be suctioned through suction tube 516 andthrough a lumen of tube 512, thereby providing for maintenance of asubstantially dry environment adjacent to the upper surface of theoccluder 510. The occluder 510 may comprise a balloon or any othersuitable occlusion member as described herein or known in the art. Asshown in FIGS. 3F′-3F′″ the suction tube 516 may comprise a simple tubehaving an open distal end or, alternatively, the device may incorporatea suction tube 516 a that has a plurality of side apertures 520 formednear its distal end and/or a suction tube 516 that has a guard member522, such as a screen, formed over its suction ports or openings todeter solid matter (e.g., blood clots or other debris) from clogging thesuction ports or openings.

FIG. 3G shows an occluder 530 attached to a tube 532 that has a curved(e.g., generally “U” shaped) distal end that does not protrude into theinterior of the occluder. Suction apertures 536 are formed in the distalportion of the tube 532 to permit blood, fluid or debris that collectsadjacent to the upper surface of the occluder 530 to be suctionedthrough the tube 532. In embodiments where the occluder is a balloon aballoon/inflation lumen may extend through tube 532 and a small ballooninflation tube 538 may extend into the interior of the balloon to permitthe balloon to be inflated and deflated. Optionally, in someembodiments, a separate tube 540 may extend through tube 532 and troughoccluder 530 to provide access to the area distal to the occluder 530for purposes of suctioning, introduction of instruments, or otherpurposes.

FIG. 3H shows another embodiment wherein the occluder 546 is connectedto a tube or elongate member 550 and a suction tube 548 having anexpanded (e.g., trumpet shaped) distal end is useable to suction blood,fluid or debris from the area adjacent to the upper surface of theoccluder. As can be seen from FIG. 3H, where the upper surface of theoccluder is arched and annular collection space may be created aroundthe perimeter of the occluder 546 where the occluder 546 coapts with thewall of the anatomical structure in which it is positioned (e.g., anasal cavity, posterior choanae, nasopharynx, pharynx, etc.) and theexpanded end 552 of the suction tube 548 may be sized and shaped toreceive the arched upper surface of the occluder 546 and to suction anyblood, fluid or debris from that annular collection space. Inembodiments where the occluder is a balloon a balloon/inflation lumenmay extend through tube 548 and a small balloon inflation tube mayextend into the interior of the balloon to permit the balloon to beinflated and deflated. Optionally, in some embodiments, a separate tube550 may extend through tube 548 and through occluder 546 to provideaccess to the area distal to the occluder 546 for purposes ofsuctioning, introduction of instruments or fluid injectors, or otherpurposes.

FIG. 3I shows an embodiment wherein the occluder 570 comprises a mass ofabsorbent material such as a tampon (e.g., cotton, gauze, hydrogel orother material or composite of materials that will absorb fluid andocclude the desired body lumen). In the particular example shown, theoccluder is advanced out of an aperture 578 formed in a tube 572 thathas a curved (e.g., generally “U” shaped) tip. Suction apertures 576 areformed in the distal portion of the tube 572 to permit blood, fluid ordebris that collects adjacent to the upper surface of the occluder 570to be suctioned through the tube 572. After the procedure is complete orthe occlusion is no longer required, the tube 572 and fluid-soakedoccluder 570 may be withdrawn from the body without retraction of theoccluder 570 into the tube 572. Optionally, a distal end opening 574 maybe formed in tube 572 and such distal end opening may be connected tothe same lumen as openings 576 or a separate lumen to the optionaldistal end opening 574 to be used for suctioning, irrigation orintroduction of a working device 580 such those shown in FIGS. 5A-5Y′″″and described herebelow.

FIG. 3J shows an occluder embodiment similar to that of the device shownin FIGS. 2O and 2P and described hereabove. In this embodiment, anoccluder 600 is attached to a tube or elongate member 604 and a suctiontube 602 is movable back and forth over the tube or elongate member 604to suction blood, fluid or debris from the area adjacent to the uppersurface of the occluder 600 or elsewhere in the body lumen in which theoccluder 600 is positioned. In embodiments where the occluder 600 is aballoon, a balloon/inflation lumen may extend through tube or elongatemember 604 and into the balloon to permit the balloon to be inflated anddeflated. Optionally, in some embodiments, a separate tube 606 mayextend trough tube or elongate member 604 and through occluder 600 toprovide access to the area distal to the occluder 600 for purposes ofsuctioning, introduction of instruments, or other purposes.

FIG. 3K shows an occluder embodiment similar to that incorporated intothe device shown in FIGS. 2Q and 2R and described hereabove. In thisembodiment, an occluder 610 is attached to a tube or elongate member 614and a tapered suction tube 612 having one or more suction apertures 616formed therein is movable back and forth over the tube or elongatemember 614 to suction blood, fluid or debris from the area adjacent tothe upper surface of the occluder 610 or elsewhere in the body lumen inwhich the occluder 600 is positioned. Of course, irrigation solution orother fluids may also be delivered through such apertures 616 or througha separate irrigation/infusion lumen that opens through separateirrigation/infusion aperture(s) (not shown). In embodiments where theoccluder 610 is a balloon, a balloon/inflation lumen may extend throughtube or elongate member 614 and into the balloon to permit the balloonto be inflated and deflated. Optionally, in some embodiments, a separatetube 618 may extend trough tube or elongate member 614 and throughoccluder 610 to provide access to the area distal to the occluder 610for purposes of suctioning, introduction of instruments, or otherpurposes.

FIGS. 3L′-3L″ show yet another occluder/tubing device 1000 comprising anouter tube 1002 and an inner tube 1004 disposed coaxially within theouter tube 1002. An outwardly bendable region 1006 is formed in the wallof the outer tube 1002 near its distal end. The distal end of the outertube 1002 is affixed to the inner tube 1004. A passageway 1010 extendsbetween the outer tube 1002 and inner tube 1004 and openings 1008 areformed in the wall of the outer tube 1002. In routine operation, thisdevice 1000 is initially disposed in the configuration shown in FIG. 3L′and is inserted into the desired passageway. Thereafter, the inner tube1004 is pulled in the proximal direction while the outer tube 1002 isheld stationary, thereby causing the outwardly bendable region 1006 toprotrude outwardly as shown in FIG. 3L″ and resulting in occlusion ofthe body lumen in which the distal portion of the device 1000 ispositioned. Suction may be applied to passageway 1010 to remove blood,fluid or other debris from the area adjacent to the upper surface of1007 of the outwardly protruding bendable region 1006. In this regard,the openings 1008 may be formed close to and/or even in the uppersurface 1007 of the outwardly protruding bendable region 1006.

FIGS. 3M′ and 3M″ show another occluder/tubing device 1020 comprising anouter tube 1022 an inner tube 1024. The inner tube 1024 is advanceableout of the distal end of the outer tube 1022 and a distal portion of theinner tube 1024 expands as it emerges from the inner tube, therebyforming an occluder that occludes the body lumen or passageway in whichit is positioned, as shown in FIG. 3M″. Blood, other fluid or debris maybe suctioned from the area adjacent to the upper surface of the occluderthrough the open distal end of the outer tube 1022 and/or throughoptional side apertures 1026.

FIG. 4 shows a nasopharyngeal occluder/endotracheal tube device 620 ofthe present invention inserted through the right nasal cavity and intothe trachea. This device 620 comprises a curved tube 622 having aposterior occluder 626 positioned at or near the distal end of the tube622 and, optionally an anterior occluder (shown in dotted lines on FIG.4) formed near the proximal end of the tube 622. An endotracheal tube624 extends through curved tube 622, through the posterior occluder andinto the patient's trachea. Optionally, a cuff 628 may be formed onendotracheal tube 624 to provide a second substantially fluid tight sealwithin the patient's trachea, inferior to the glottis. A hub 630 isformed on the proximal end of tube 622. A ventilator tube 634 extendsfrom the hub and is connected to endotracheal tube 624 and is attachableto a ventilator, anesthesia machine, t-tube, Ambu-bag, etc. Inembodiments where the posterior occluder 626 is a balloon, a posterioroccluder inflation/deflation connector 632 extends from hub 630 and isconnected to an inflation/deflation lumen that extends through tube 622for inflation/deflation of the posterior occluder 626. A cuffinflation/deflation connector 634 may also extend from hub 630 andthrough the endotracheal tube 624 for inflation/deflation of theendotracheal tube cuff 628. Optionally, suction and/or device insertionports may also be formed in hub 630, as described above in connectionwith other occluder/access devices. In routine operation, this device620 is inserted to a position where the posterior occluder 626 occludesthe posterior choanae, nasopharynx or pharynx posterior to the nasalseptum (but typically superior to the glottis) and the endotracheal tube624 extends into the patient's trachea with the optional cuff positionedin the trachea inferior to the glottis.

C. Working Devices for Delivering Substances or for Cutting, Ablating,Remodeling or Expanding Bone or Soft Tissue

The present invention provides a variety of apparatus that may beinserted into the nasal cavity, paranasal sinus, nasopharynx or middleear to perform diagnostic or therapeutic procedures. These devices maybe delivered through or incorporated into flexible catheters or flexiblerod-like shafts. Such flexible construction allows these devices to bedelivered and positioned to perform the desired diagnostic ortherapeutic procedures with minimal trauma to other tissues, as canresult from the insertion of rigid scopes and rigid instruments inaccordance with the methodology of the prior art. It is within the scopeof this approach that these devices may be partially flexible or haverigid portions and flexible portions to facilitate their control andguidance to the appropriate region. Further, they may be used inconjunction or combination with other standard rigid apparatus (scopes,etc.) during some part of the procedure, if desired.

Also, in some but not necessarily all procedures, these working devices(and/or the catheters used to deliver them) may be inserted throughlumens of the occluder & access devices 10, 12, 300, 301, 400, 430, etc.as shown in FIGS. 2A-2R and described above. As stated earlier, it mayalso be desirable to focus the access and occlusion to an even smallerterritory, through stand-alone guide catheters or subselective guidecatheters with or without balloons or other occluders.

Optionally, any of the working devices and guide catheters describedherein may be configured to receive or be advanced over a guidewireunless to do so would render the device inoperable for its intendedpurpose. Some of the specific examples described herein includeguidewires, but it is to be appreciated that the use of guidewires andthe incorporation of guidewire lumens is not limited to only thespecific examples in which guidewires or guidewire lumens are shown. Theguidewires used in this invention may be constructed and coated as iscommon in the art of cardiology. This may include the use of coils,tapered or non-tapered core wires, radiopaque tips and/or entirelengths, shaping ribbons, variations of stiffness, PTFE, silicone,hydrophilic coatings, polymer coatings, etc. For the scope of thisinventions, these wires may possess dimensions of length between 5 and75 cm and outer diameter between 0.005″ and 0.050″.

Also, some of the working devices shown in FIGS. 5A-5Y′″″ and describedherein incorporate assemblies, components or mechanisms (e.g., rotatingcutters, radiofrequency electrodes, electrocautery devices, receptaclesfor capturing matter, cryosurgical apparatus, balloons, stents,radioactive or substance-eluting coatings, snares, electro-anatomicalmapping and guidance, optical fibers, lenses and other endoscopeapparatus, seals, hemostatic valves, etc. The designs and constructionsof such components and assemblies are will known in the art.Non-limiting examples of some such designs and constructions are setforth in U.S. Pat. Nos. 5,722,984 (Fischell et al.), 5,775,327 (Randolphet al.), 5,685,838 (Peters, et al.), 6,013,019 (Fischell et al.),5,356,418 (Shturman), 5,634,908 (Loomas), 5,255,679 (Imran), 6,048,299(Hoffman), 6,585,794 (Wright et al.), 6,503,185 (Waksman), 6,669,689(Lehmann et al.), 6,638,233 (Corvi et al.), 5,026,384 (Farr et al.),4,669,469 (Gifford et al.), 6,685,648 (Flaherty et al.), 5,250,059(Andreas et al.), 4,708,834 (Tsuno), 5,171,233 (Amplatz), 6,468,297(Williams et al.) and 4,748,869 (Wardle).

As shown in the examples of FIGS. 5A-5Y′″″ these working devices includeguide catheters, substance delivery catheters, scopes, injectors,cutters, bone breaking apparatus, balloons and other dilators,laser/thermal delivery devices, braces, implants, stents, snares, biopsytools, forceps, etc.

FIG. 5A shows a side suction and/or cutting catheter 70 comprising aflexible catheter body 72 having a side opening 74. The catheter 72 isadvanced into a passageway such as a nostril, nasal cavity, meatus,ostium, interior of a sinus, etc. and positioned so that the opening 74is adjacent to matter (e.g., a polyp, lesion, piece of debris, tissue,blood clot, etc.) that is to be removed. Suction may be applied througha lumen of the catheter 72 to suction the matter through the opening 74and into the catheter 72. In some cases, a cutter such as a rotatingcutter, linear slicer, pincher, laser beam, electrosurgical cutter, etc.may be incorporated into the catheter 72 to assist in severing orablating tissue or other matter that has been positioned in the sideopening 74. This catheter may incorporate a deflectable tip or a curveddistal end which may force the opening of the catheter against thetissue of interest. Further, this device 70 may have an optionalstabilizing balloon (similar to that shown in FIG. 5M and describedherebelow) incorporated on one side of the catheter 72 to press itagainst the tissue of interest and may also contain one or more on-boardimaging modalities such as ultrasound, fiber or digital optics, OCT, RFor electro-magnetic sensors or emitters, etc.

FIG. 5 B shows an injector catheter 76 that comprises a flexiblecatheter shaft 78 having one or more injector(s) 80 that are advanceableinto tissue or other matter that is located in or on the wall of thebody lumen in which the catheter 78 is positioned. The catheter 78 isadvanced, with the injector(s) retracted into the catheter body, througha passageway such as a nostril, nasal cavity, meatus, ostium, interiorof a sinus, etc. and positioned adjacent the area to which a diagnosticor therapeutic substance is to be injected. Thereafter, the injector(s)are advanced into the adjacent tissue or matter and the desiredsubstance is injected. Energy, such as laser, RF, thermal or otherenergy may be delivered through these injectors 80 or energy emittingimplants (such as gamma or beta radioactive seeds) may also be deliveredthrough these injectors 80, either alone or in combination with a fluidcarrier or other substance such as a diagnostic or therapeutic substance(as defined herein). It will be noted that this device 76 as well asother working devices and methods of the present invention (includingthe various implantable devices described herein) are useable to deliverdiagnostic or therapeutic substances. The term “diagnostic ortherapeutic substance” as used herein is to be broadly construed toinclude any feasible drugs, prodrugs, proteins, gene therapypreparations, cells, diagnostic agents, contrast or imaging agents,biologicals, etc. For example, in some applications where it is desiredto treat or prevent a microbial infection, the substance delivered maycomprise pharmaceutically acceptable salt or dosage form of anantimicrobial agent (e.g., antibiotic, antiviral, antiparacytic,antifungal, etc.).

Some nonlimiting examples of antimicrobial agents that may be used inthis invention include acyclovir, amantadine, aminoglycosides (e.g.,amikacin, gentamicin and tobramycin), amoxicillin,amoxicillin/Clavulanate, amphotericin B, ampicillin,ampicillin/sulbactam, atovaquone, azithromycin, cefazolin, cefepime,cefotaxime, cefotetan, cefpodoxime, ceftazidime, ceftizoxime,ceftriaxone, cefuroxime, cefuroxime axetil, cephalexin, chloramphenicol,clotrimazole, ciprofloxacin, clarithromycin, clindamycin, dapsone,dicloxacillin, doxycycline, erythromycin, fluconazole, foscarnet,ganciclovir, atifloxacin, imipenem/cilastatin, isoniazid, itraconazole,ketoconazole, metronidazole, nafcillin, nafcillin, nystatin, penicillin,penicillin G, pentamidine, piperacillin/tazobactam, rifampin,quinupristin-dalfopristin, ticarcillin/clavulanate,trimethoprim/sulfamethoxazole, valacyclovir, vancomycin, mafenide,silver sulfadiazine, mupirocin, nystatin, triamcinolone/nystatin,clotrimazole/betamethasone, clotrimazole, ketoconazole, butoconazole,miconazole, tioconazole, detergent-like chemicals that disrupt ordisable microbes (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride,menfegol, and N-docasanol); chemicals that block microbial attachment totarget cells and/or inhibits entry of infectious pathogens (e.g.,sulphated and sulponated polymers such as PC-515 (carrageenan),Pro-2000, and Dextrin 2 Sulphate); antiretroviral agents (e.g., PMPAgel) that prevent retroviruses from replicating in the cells;genetically engineered or naturally occurring antibodies that combatpathogens such as anti-viral antibodies genetically engineered fromplants known as “plantibodies;” agents which change the condition of thetissue to make it hostile to the pathogen (such as substances whichalter mucosal pH (e.g., Buffer Gel and Acidform) or non-pathogenic or“friendly” bacteria or other microbes that cause the production ofhydrogen peroxide or other substances that kill or inhibit the growth ofpathogenic microbes (e.g., lactobacillus). As may be applied to any ofthe substances listed previously or below, these substances may becombined with any one or more drug-releasing devices or molecularconstructs such as polymers, collagen, gels, implantable osmotic pumpdevices, etc. to permit their release over an extended period of timeonce deposited. Further, these substances may also be combined with anyof the implantable structural devices described below (stents,expanders, etc.) to reduce infection, encrustation, or encapsulation ofthe implant itself, or to allow the drug to be deposited in the optimallocation mucosally, sub-mucosally or into the bone. Examples ofimplantable substance delivery devices useable in this invention includethose shown in FIGS. 5Y′-5Y′″″ and described herebelow.

Additionally or alternatively, in some applications where it is desiredto treat or prevent inflammation the substances delivered in thisinvention may include various steroids. For example, corticosteroidsthat have previously administered by intranasal administration may beused, such as beclomethasone (Vancenase® or Beconase®), flunisolide(Nasalide®), fluticasone (Flonase®), triamcinolone (Nasacort®) andmometasone (Nasonex®). Also, other steroids that may be useable in thepresent invention include but are not limited to aclometasone, desonide,hydrocortisone, betamethasone, clocortolone, desoximetasone,fluocinolone, flurandrenolide, mometasone, prednicarbate; amcinonide,desoximetasone, diflorasone, fluocinolone, fluocinonide, halcinonide,clobetasol, augmented betamethasone, diflorasone, halobetasol,prednisone, dexamethasone and methylprednisolone,

Additionally or alternatively, in some applications, such as those whereit is desired to treat or prevent an allergic or immune response, thesubstances delivered in this invention may include a) various cytokineinhibitors such as humanized anti-cytokine antibodies, anti-cytokinereceptor antibodies, recombinant (new cell resulting from geneticrecombination) antagonists, or soluble receptors; b) various leucotrienemodifiers such as zafirlukast, montelukast and zileuton; c)immunoglobulin E (IgE) inhibitors such as Omalizumab (an anti-IgEmonoclonal antibody formerly called rhu Mab-E25) and secretory leukocyteprotease inhibitor).

Additionally or alternatively, in some applications, such as those whereit is desired to shrink mucosal tissue, cause decongestion or effecthemostasis, the substances delivered in this invention may includevarious vasoconstrictors for decongestant and or hemostatic purposesincluding but not limited to pseudoephedrine, xylometazoline,oxymetazoline, phenylephrine, epinephrine, etc.

Additionally or alternatively, in some applications, such as those whereit is desired to facilitate the flow of mucous, the substances deliveredin this invention may include various mucolytics or other agents thatmodify the viscosity or consistency of mucous or mucoid secretions,including but not limited to acetylcysteine (Mucomyst™, Mucosil™) andguaifenesin.

Additionally or alternatively, in some applications such as those whereit is desired to prevent or deter histamine release, the substancesdelivered in this invention may include various mast cell stabilizers ordrugs which prevent the release of histamine such as cromolyn (e.g.,Nasal Chrom®) and nedocromil.

Additionally or alternatively, in some applications such as those whereit is desired to prevent or inhibit the effect of histamine, thesubstances delivered in this invention may include variousantihistamines such as azelastine (e.g., Astylin®), diphenhydramine,loratidine, etc.

Additionally or alternatively, in some embodiments such as those whereit is desired to dissolve, degrade, cut, break or remodel bone orcartilage, the substances delivered in this invention may includesubstances that weaken or modify bone and/or cartilage to facilitateother procedures of this invention wherein bone or cartilage isremodeled, reshaped, broken or removed. One example of such an agentwould be a calcium chelator such as EDTA that could be injected ordelivered in a substance delivery implant next to a region of bone thatis to be remodeled or modified. Another example would be a preparationconsisting or containing bone degrading cells such as osteoclasts. Otherexamples would include various enzymes of material that may soften orbreak down components of bone or cartilage such as collagenase (CGN),trypsin, trypsin/EDTA, hyaluronidase, and tosyllysylchloromethane(TLCM).

Additionally or alternatively, in some applications, the substancesdelivered in this invention may include other classes of substances thatare used to treat rhinitis, nasal polyps, nasal inflammation, and otherdisorders of the ear, nose and throat including but not limited toanticolinergic agents that tend to dry up nasal secretions such asipratropium (Atrovent Nasal®), as well as other agents not listed here.

Additionally or alternatively, in some applications such as those whereit is desired to draw fluid from polyps or edematous tissue, thesubstances delivered in this invention may include locally or topicallyacting diuretics such as furosemide and/or hyperosmolar agents such assodium chloride gel or other salt preparations that draw water fromtissue or substances that directly or indirectly change the osmolarcontent of the mucous to cause more water to exit the tissue to shrinkthe polyps directly at their site.

Additionally or alternatively, in some applications such as thosewherein it is desired to treat a tumor or cancerous lesion, thesubstances delivered in this invention may include antitumor agents(e.g., cancer chemotherapeutic agents, biological response modifiers,vascularization inhibitors, hormone receptor blockers, cryotherapeuticagents or other agents that destroy or inhibit neoplasia ortumorigenesis) such as; alkylating agents or other agents which directlykill cancer cells by attacking their DNA (e.g., cyclophosphamide,isophosphamide), nitrosoureas or other agents which kill cancer cells byinhibiting changes necessary for cellular DNA repair (e.g., carmustine(BCNU) and lomustine (CCNU)), antimetabolites and other agents thatblock cancer cell growth by interfering with certain cell functions,usually DNA synthesis (e.g., 6 mercaptopurine and 5-fluorouracil (5FU),antitumor antibiotics and other compounds that act by binding orintercalating DNA and preventing RNA synthesis (e.g., doxorubicin,daunorubicin, epirubicin, idarubicin, mitomycin-C and bleomycin) plant(vinca) alkaloids and other anti-tumor agents derived from plants (e.g.,vincristine and vinblastine), steroid hormones, hormone inhibitors,hormone receptor antagonists and other agents which affect the growth ofhormone-responsive cancers (e.g., tamoxifen, herceptin, aromataseinhibitors such as aminoglutethamide and formestane, triazole inhibitorssuch as letrozole and anastrazole, steroidal inhibitors such asexemestane), antiangiogenic proteins, small molecules, gene therapiesand/or other agents that inhibit angiogenesis or vascularization oftumors (e.g., meth-1, meth-2, thalidomide), bevacizumab (Avastin),squalamine, endostatin, angiostatin, Angiozyme, AE-941 (Neovastat),CC-5013 (Revimid), medi-522 (Vitaxin), 2-methoxyestradiol (2ME2,Panzem), carboxyamidotriazole (CAI), combretastatin A4 prodrug (CA4P),SU6668, SU11248, BMS-275291, COL-3, EMD 121974, IMC-1C11, IM862,TNP-470, celecoxib (Celebrex), rofecoxib (Vioxx), interferon alpha,interleukin-12 (IL-12) or any of the compounds identified in ScienceVol. 289, Pages 1197-1201 (Aug. 17, 2000) which is expresslyincorporated herein by reference, biological response modifiers (e.g.,interferon, bacillus calmette-guerin (BCG), monoclonal antibodies,interluken 2, granulocyte colony stimulating factor (GCSF), etc.), PGDFreceptor antagonists, herceptin, asparaginase, busulphan, carboplatin,cisplatin, carmustine, cchlorambucil, cytarabine, dacarbazine,etoposide, flucarbazine, fluorouracil, gemcitabine, hydroxyurea,ifosphamide, irinotecan, lomustine, melphalan, mercaptopurine,methotrexate, thioguanine, thiotepa, tomudex, topotecan, treosulfan,vinblastine, vincristine, mitoazitrone, oxaliplatin, procarbazine,streptocin, taxol, taxotere, analogs/congeners and derivatives of suchcompounds as well as other antitumor agents not listed here.

Additionally or alternatively, in some applications such as those whereit is desired to grow new cells or to modify existing cells, thesubstances delivered in this invention may include cells (mucosal cells,fibroblasts, stem cells or genetically engineered cells) as well asgenes and gene delivery vehicles like plasmids, adenoviral vectors ornaked DNA, mRNA, etc. injected with genes that code foranti-inflammatory substances, etc., and, as mentioned above, osteoclaststhat modify or soften bone when so desired.

Additionally or alternatively to being combined with a device and/or asubstance releasing modality, it may be ideal to position the device ina specific location upstream in the mucous flow path (i.e. frontal sinusor ethmoid cells). This could allow the deposition of fewer drugreleasing devices, and permit the “bathing” of all the downstreamtissues with the desired drug. This utilization of mucous as a carrierfor the drug may be ideal, especially since the concentrations for thedrug may be highest in regions where the mucous is retained; whereasnon-diseased regions with good mucouse flow will be less affected by thedrug. This could be particularly useful in chronic sinusitis, or tumorswhere bringing the concentration of drug higher at those specific sitesmay have greater therapeutic benefit. In all such cases, local deliverywill permit these drugs to have much less systemic impact. Further, itmay be ideal to configure the composition of the drug or delivery systemsuch that it maintains a loose affinity to the mucous permitting it todistribute evenly in the flow. Also, in some applications, rather than adrug, a solute such as a salt or other mucous soluble material may bepositioned at a location whereby mucous will contact the substance and aquantity of the substance will become dissolved in the mucous therebychanging some property (e.g., pH, osmolarity, etc) of the mucous. Insome cases, this technique may be used to render the mucous hyperosmolarso that the flowing mucous will draw water from polyps, edematousmucosal tissue, etc. thereby providing a desiccating therapeutic effect.

Additionally or alternatively to substances directed towards localdelivery to affect changes within the sinus cavity, the nasal cavitiesprovide unique access to the olfactory system and thus the brain. Any ofthe devices and methods described herein may also be used to deliversubstances to the brain or alter the functioning of the olfactorysystem. Such examples include, the delivery of energy or the depositionof devices and/or substances and/or substance delivering implant(s) toocclude or alter olfactory perception, to suppress appetite or otherwisetreat obesity, epilepsy (e.g., barbiturates such as phenobarbital ormephoobarbital; iminostilbenes such as carbamazepine and oxcarbazepine;succinimides such as ethylsuximide; valproic acid; benzodiazepines suchas clonazepam, clorazepate, diazepam and lorazepam, gabapentin,lamotrigine, acetazolamide, felbamate, levetiraceam, tiagabine,topiramate, zonisamide, etc.), personality or mental disorders (e.g.,antidepressants, antianxiety agents, antipsychotics, etc.), chronicpain, Parkinson's disease (e.g., dopamine receptor agonists such asbromocriptine, pergolide, ropinitrol and pramipexole; dopamineprecursors such as levodopa; COMT inhibitors such as tolcapone andentacapone; selegiline; muscarinic receptor antagonists such astrihexyphenidyl, benztropine and diphenhydramine) and Alzheimer's,Huntington's Disease or other dementias, disorders of cognition orchronic degenerative diseases (e.g. tacrine, donepezil, rivastigmine,galantamine, fluoxetine, carbamazepine, clozapine, clonazepam andproteins or genetic therapies that inhibit the formation of beta-amyloidplaques), etc.

FIG. 5C shows a device 82 that comprises a rotating shaft 84 having adrill, auger or burr 86 that is useable to drill, bore, grind or cutthrough tissue, bone, cartilage or other matter. This device 82 maydeployed as shown or, alternatively, the device 82 may be insertedthrough a small mucosal incision to preserve the overlying mucosallining while removing or boring into the bone or cartilage below themucosal lining.

FIG. 5D shows a guided injector catheter device 88 for delivering adiagnostic or therapeutic substance as defined above. This device 88comprises a flexible catheter 90 having an imaging apparatus 96 thereonand an injector 92 that is advanceable from and retractable into thecatheter 90. The imaging apparatus 96 is useable to image the targetlocation 94 at which the substance is to be deposited and to enableorientation of the catheter 88 such that, when the injector 92 isadvanced from the catheter 88, the injector 92 will travel to thedesired target location 94. Examples of such catheter 88 are describedin U.S. Pat. Nos. 6,195,225 (Makower), 6,544,230(Flaherty et al.),6,375,615 (Flaherty et al.), 6,302,875 (Makower et al), 6,190,353(Makower et al.) and 6,685,648 (Flaherty et al.), the entireties ofwhich are expressly incorporated herein by reference.

FIG. 5E shows a balloon catheter device 98 comprising a flexiblecatheter 100 having a balloon 102 thereon. The catheter device 98 isadvanced, with balloon 102 deflated, into a passageway such as anostril, nasal cavity, meatus, ostium, interior of a sinus, etc. andpositioned with the deflated balloon 102 situated within an ostium,passageway or adjacent to tissue or matter that is to be dilated,expanded or compressed (e.g., to apply pressure for hemostasis, etc.).Thereafter, the balloon 102 may be inflated to dilate, expand orcompress the ostium, passageway, tissue or matter. Thereafter theballoon 102 may be deflated and the device 98 may be removed. Thisballoon 102 may also be coated, impregnated or otherwise provided with amedicament or substance that will elute from the balloon into theadjacent tissue (e.g., bathing the adjacent tissue with drug orradiating the tissue with thermal or other energy to shrink the tissuesin contact with the balloon 102). Alternatively, in some embodiments,the balloon may have a plurality of apertures or openings through whicha substance may be delivered, sometimes under pressure, to cause thesubstance to bathe or diffuse into the tissues adjacent to the balloon.Alternatively, in some embodiments, radioactive seeds, threads, ribbons,gas or liquid, etc. may be advanced into the catheter shaft 100 orballoon 102 or a completely separate catheter body for some period oftime to expose the adjacent tissue and to achieve a desired diagnosticor therapeutic effect (e.g. tissue shrinkage, etc.).

FIG. 5F shows a balloon/cutter catheter device 104 comprising a flexiblecatheter 106 having a balloon 108 with one or more cutter blades 110formed thereon. The device 104 is advanced, with balloon 108 deflated,into a passageway such as a nostril, nasal cavity, meatus, ostium,interior of a sinus, etc. and positioned with the deflated balloon 108situated within an ostium, passageway or adjacent to tissue or matterthat is to be dilated, expanded or compressed and in which it is desiredto make one or more cuts or scores (e.g. to control the fracturing oftissue during expansion and minimize tissue trauma etc.). Thereafter,the balloon 108 may be inflated balloon to dilate, expand or compressthe ostium, passageway, tissue or matter and causing the cutter blade(s)110 to make cut(s) in the adjacent tissue or matter. Thereafter theballoon 108 may be deflated and the device 104 may be removed. The blademay be energized with mono or bi-polar RF energy or simply be thermallyheated to part the tissues in a hemostatic fashion, as well as causecontraction of collagen fibers or other connective tissue proteins,remodeling or softening of cartilage, etc.

FIGS. 5G′-5G′″ show a device 160 and method for delivery of a pressureexpandable stent 166. This device 160 comprises a flexible catheter 162having a balloon 164 thereon. Initially, as shown in FIG. 5G′, theballoon 164 is deflated and the stent 166 is radially compressed to acollapsed configuration, around the deflated balloon 164. The catheter162 with the balloon 164 deflated and the collapsed stent 166 mountedthereon is advanced into a passageway such as a nostril, nasal cavity,meatus, ostium, interior of a sinus, etc. that is to be stented.Thereafter, the balloon 164 is inflated causing the stent 166 to expandto a size that frictionally engages the surrounding tissue so as to holdthe stent 166 in place, as shown in FIG. 5G″. In some instances theprocedure will be performed for the purpose of enlarging a passageway(e.g., an ostium, meatus, etc.) and the stent 166 will be expanded to adiameter that is sufficiently large to cause the desired enlargement ofthe passageway and the stent will then perform a scaffolding function,maintaining the passageway in such enlarged condition. After the stent166 has been fully expanded and implanted, the balloon 164 may bedeflated and the catheter 162 removed as shown in FIG. 5G′″. In someapplications, the stent may contain a diagnostic or therapeuticsubstance as defined herein and such substance may elute from the stent166 into the surrounding tissue to bring about a desired diagnostic ortherapeutic effect. In some cases, the stent 166 may be permanentlyimplanted. In other cases the stent 166 may be temporarily implanted. Incases where the stent 166 is temporarily implanted, it may be removed ina second procedure conducted to retrieve the stent 166 or the stent 166may be made of bioabsorbable or biodegradable material such that itdegrades or is absorbed within a desired period of time afterimplantation. In some cases, such as when the stent is to be placedwithin the ostium of a paranasal sinus, the stent and/or the balloon maybe specifically shaped to facilitate and/or cause the stent 166 to seatin a desired position and to prevent unwanted slippage of the stent 166.For example, the stent 166 and/or balloon 164 may have an annular grooveformed about the middle thereof or may be hourglass or venture shaped,to facilitate seating of the stent 166 within an ostium or orificewithout longitudinal slippage of the stent 166. In some cases it may bedesirable to leave a tether or suture attached to the stent 166 to allowfor simple removal of the stent 166 in the physician's office or othersuitable location. In some cases the procedure may be intended toactually break bone (e.g., where the stent is intended to dilate orenlarge a sinus ostium). Thus, the balloon 164 may be made of polymericmaterial including, but not limited to flexible polyvinyl chloride(PVC), polyethylene terephthalate (PET), cross-linked polyethylene,polyester, polyamide, polyolefin, polyurethane and silicone. Variousballoon properties (strength, flexibility, thickness, etc.) may bemodified by, but not limited to, blending, layering, mixing,co-extruding, irradiating, and other means of engineering balloonmaterial(s). This allows for the use of compliant balloons that canconform to the surrounding structure or non-compliant balloons that candeform or break the surrounding structures (e.g., bone).

FIG. 5H shows an electrosurgical device 208 comprising a flexible shaft210 (e.g., a catheter or solid shaft) having arched strut members 214attached thereto. Electrodes 216 are located on the strut members 214.In some cases, the strut members may be of fixed configuration and inother cases the strut members 214 may be collapsible and expandable. Inoperation, the device 208 is advanced into a passageway such as anostril, nasal cavity, meatus, ostium, interior of a sinus, etc.Thereafter, current is applied to the electrodes 216 causing tissueadjacent to the struts 214 to be cauterized or heated. The electrodes216 may be bipolar, monopolar or facilitated by any other suitable formof energy such as a gas or plasma arc. Additionally, sensing elementsmay also be attached to the catheter and/or strut members to monitorvarious parameters of the catheter and/or surrounding tissue (e.g.,temperature, etc.). In instances where monopolar electrodes are used, aseparate antenna electrode (not shown) will be applied to the patient'sbody in accordance with processes and techniques that are well known inthe art.

FIG. 5I shows a device 218 that delivers a flow 222 of material (e.g.,cryogenic material, diagnostic or therapeutic agent, etc.) or energy(laser light, infrared light, etc.) to the tissues adjacent to thepassage or body cavity in which the device 218 is positioned. Thisdevice comprises a flexible catheter 220 with an outlet aperture or lensat or near its distal end, through which the flow of material or energyis delivered. This device may be used to cryogenically freeze polyps orother tissues or to deliver laser energy to turbinates or other tissuesfor the purpose of ablating the tissue or to heat the tissue to atemperature that results in shrinking of the tissue.

FIG. 5J shows an implantable pressure exerting device 224 that isimplantable within a passageway such as a nostril, nasal cavity, meatus,ostium, interior of a sinus, etc. to exert pressure on bone, cartilage,soft tissue, etc. Examples of situations where it is desirable to applysuch pressure to an anatomical structure include those wherein it isdesired to splint or maintain approximation of a broken bone or thosewherein it is desired to cause remodeling or gradual repositioning orreshaping of bone, cartilage, soft tissue or other structures. Thisimplantable device 224 comprises a pressure exerting member 228 and twoor more plate members 226. The device 224 is initially constrained in acollapsed configuration wherein the pressure exerting member 228 iscompressed or collapsed and the device 224 is advanced into a passagewaysuch as a nostril, nasal cavity, meatus, ostium, interior of a sinus,etc. where it is desired to apply pressure to an anatomical structure.When the device 224 is in the desired position, the pressure exertingmember 228 is expanded or elongated to exert outward pressure on theplate members 226 and onto the anatomical structures against which theplate members 226 are positioned. In some embodiments, the pressureexerting member may comprise a spring. In other embodiments, thepressure exerting member may comprise a ratchet, hydraulic cylinder orother mechanical apparatus that may be adjusted to create a desiredamount of pressure on the plate members 226. In some applications, thepressure exerting member 228 may be adjustable in situ (i.e., with thedevice implanted in the body) so as to allow the operator toperiodically change the amount of pressure being applied to theanatomical structures of interest (e.g., the operator may change toposition of a ratchet or add fluid to a hydraulic cylinder) therebybringing about gradual remodeling or movement of an anatomical structurein a manner similar to that achieved during dental orthodontia. Thus,this pressure exerting device 224 has broad applicability in a varietyof procedures including those intended to enlarge a sinus ostium or tostraighten an intranasal septum.

FIGS. 5K-5K′ and 5L show a forward rotary cutting catheter device 700that comprises a flexible outer tube 702 and a flexible inner tube 704disposed coaxially and rotatably mounted within the outer tube 702. Oneor more bearings 708 (e.g., a helical bearing or a series of individualcylindrical bearings) may be disposed between the outer tube 702 andinner tube 704, as shown. Alternatively, one or both apposing tubesurfaces may be made of, lined with, or be coated by etc. a lubriciousmaterial such as silicone or PTFE to facilitate movement. A rotatingcutter 706 is positioned on the distal end of the inner tube 704. Inoperation, as shown in FIG. 5K′, the device 700 is advanced through apassageway such as a nostril, nasal cavity, meatus, ostium, interior ofa sinus, etc. to a position where the distal end of the device 700 ispositioned just behind some obstructive matter, such as a polyp P. Theinner tube 704 and its cutter 706 are rotated as the device is advancedinto the obstructive matter P and/or suction is applied through thelumen of the inner tube 704 and/or through the lumen of the outer tube702 to draw the obstructive matter P into contact with the rotatingcutter 706. It is to be appreciated that, although this embodiment showsa rotating cutter 706, various other types of cutters such as lasers,radiofrequency cutters and other mechanical cutters, etc. may be usedinstead. As the obstructive matter P is severed by the rotating cutter706 the obstructive matter P or pieces thereof may be suctioned throughthe lumen of the inner tube 704 and/or through the lumen of the outertube 702. In some applications, as shown in FIG. 5L, a scope orguidewire 710 may extend through the lumen of the inner tube tofacilitate advancement and positioning of the device 700 prior to theremoval of the obstructive matter P.

FIGS. 5M and 5N show a side rotary cutting device 714 comprising aflexible outer tube 718 and a flexible inner tube 722 that is disposedcoaxially and rotatably mounted within the outer tube 718. One or morebearings 730 (e.g., a helical bearing or a series of individualcylindrical bearings) may be disposed between the outer tube 718 andinner tube 722, as shown. Alternatively, one or both apposing tubesurfaces may be made of, lined with, or be coated by etc. a lubriciousmaterial such as silicone or PTFE to facilitate movement. A rotatingcutter 724 is positioned on the distal end of the inner tube 722. A sideopening 720 is formed in the outer tube 718 and the cutter 724 ispositioned proximal to the side opening 720. A pull member 728 extendsthrough the inner tube 722 and is attached to a retractor head 726. Inoperation, the device 714 is advanced and/or torqued to a position wherethe side opening 720 is near a polyp, tissue or other obstructive matterto be removed. The inner tube 722 and its cutter 724 are rotated. Insome applications, suction may be applied through the inner tube 722and/or through the lumen of the outer tube 718 to draw the obstructivematter into the side opening 720. The pull member 728 is pulled in theproximal direction, causing the retractor head 726 to retract or pullthe obstructive matter into contact with the rotating cutter 724. As theobstructive matter is severed by the rotating cutter, the severedobstructive matter or pieces thereof may be suctioned through the lumenof the inner tube 722 and/or through the lumen of the outer tube 718.The pull member 728 may then be advanced in the distal direction toreturn the retractor head 726 to its original position as shown in FIGS.5M and 5N. An optional balloon 719 or other laterally extendable membermay be located on the side of the catheter 718 opposite the side opening720 to push the side opening 720 against a lumen wall or into thedirection of a polyp or other tissue to be removed. Alternatively, thecatheter may incorporate a deflectable tip or a curved distal end thatmay force the side opening of the catheter against a lumen wall or intothe direction of a polyp or other tissue to be removed. With specificreference to FIG. 5N, there is shown a side rotary cutting device 714 athat includes all of the elements of the device 714 shown in FIG. 5M,but includes a side lumen 731. A scope may be permanently positionedwithin this side lumen 731 or a scope may be temporarily inserted into(or through) the side lumen 731 to enable the operator to view the areanear the side opening 720 and to facilitate the advancement andpositioning of the device 714A. Also, the side lumen 731 may function asa guidewire lumen to allow the device 714A to be advanced over aguidewire.

It is to be understood that any of the devices described within thisdocument may be further modified to include any one of the followingdevices within its structure: electromagnetic positioningsensor/detector (Biosense/JNJ, Surgical NavigationTechnologies/Medtronic, Calypso Medical), RF sensor/transmitter,magnetic direction localizer (Stereotaxis, Inc.), thermal sensor,radiopaque composition, radioactive detection emitter/sensor, ultrasonicscanner/transmitter/receiver, Doppler scanner, electrical stimulator,fiber optic, digital optic, local diagnostic chip containing elementsresponsive to the presence or absence of certain substances andtherefore having the ability to diagnose the presence of fungus,microbes, viruses, blood, abnormal mucous content, cancer cells, drugsof abuse, genetic abnormalities, metabolic bi-products, etc.

It is to be further understood that any and all of the devices describedin this patent application may incorporate, or may be used inconjunction with, endoscopes. Such endoscopes will typically includelight transmitting optical fibers for casting light in the area to beviewed by the scope and image transmitting optical fibers for carryingan image received by the scope to an eyepiece or monitor device locatedoutside the patient's body. In some embodiments a scope, such as adisposable and/or flexible scope, may be affixed to the working device.Examples of such endoscopes that are suitable for incorporation into theworking devices of this invention include that described in U.S. Pat.Nos. 4,708,434; 4,919,112; 5,127,393; 5,519,532; 5,171,233, 5,549,542,6,551,239 and 6,572,538 as well as published United States PatentApplication No. 2001/0029317A1, the entireties of which are expresslyincorporated herein by reference.

It is to be further understood that any catheters or elongate flexibledevices of this invention may include design elements that impactperformance features which include, but are not limited to, durability,flexibility, stiffness, length, profile, lubricity, trackability,steerability, torqueability, deflectability, guidance, and radiopacity.Design elements can include, but are not limited to, use of variouspolymers and metals, use of varying durometer materials to establish adesired flexibility gradient along the device,blending/mixing/layering/co-extruding etc. various materials, usingbearings or lubricious coatings or lubricious materials (e.g., silicone,PTFE, parylene, polyethene, etc.) where two or more surfaces will moverelative to each other (e.g., guidewire or instrument lumen, deflectingtendon in lumen, etc.), use of braiding or springs to increase torquecontrol over the device, using materials (e.g. barium, tantalum, etc.)to increase polymer radiopacity, and use of elements to predictablydeflect various sections of the catheter (e.g., tension straps or wires,shape memory alloys such as nitinol, etc.).

It is to be further understood that any of the catheters, scopes,elongate working devices or other devices disclosed in this patentapplication may be rendered steerable or volitionally bendable, unlessto do so would make such device inoperative for its intended purpose.Steerable catheters and scopes are well known in the art and may utilizemechanical steering assemblies (e.g., pull wires, hinges, etc.) or shapememory materials (e.g., nickel titanium alloys, shape memory polymers,etc.) to induce the device to undergo the desired bending or curvatureafter it has been inserted into the body. Examples of apparatus andconstruction that may be used to render these devices steerable orvolitionally bendable include but are not limited to those described inU.S. Pat. Nos. 5,507,725 (Savage et al.), 5,656,030 (Hunjan et al.),6,183,464 (Webster), 5,251,092 (Qin et al.), 6,500,130 (Kinsella etal.), 6,571,131 (Nguyen), 5,415,633 (Lazarus et al.), 4,998,916(Hammerslag et al.), 4,898,577 (Badger et al.), 4,815,478 (Buchbinder etal.) and published United States Patent Applications No. 200310181827A1(Hojeibane et al.) and 2003/0130598A1 (Manning et al.), the entiretiesof which are expressly incorporated herein by reference.

FIG. 5O shows a flexible catheter 733 having a working lumen 734 thatextends though the catheter 732 and terminates in a distal end opening.Optionally, a second lumen 736 may also extend though the catheter 732and terminate in a distal end opening, as shown. An endoscope 738 may bepermanently positioned within this lumen 736 or such endoscope 738 maybe temporarily inserted into (or through) the lumen 736 to enable theoperator to view the area distal to the catheter 732. Additionally oralternatively, a side scope or lumen 740 may be located on the catheter732 and an endoscope may be permanently embodied by or positioned in ortemporarily inserted into (or through) such side scope or lumen 740 toenable the operator to view the area distal to the catheter 732 and, inat least some cases, the distal end of the catheter 732 itself. In anydevices which incorporate such optional side scope or lumen 740, theside scope or lumen 740 may be of any suitable length and may terminatedistally at any suitable location and such side scope or lumen 740 isnot limited to the specific positioning and the specific distal endlocation shown in the drawings. Also, in embodiments that incorporate aside scope or lumen 740 such side lumen may be employed as a guidewireor working lumen to permit the catheter to be advanced over a guidewireor for other working devices to be inserted therethrough.

FIG. 5P shows a balloon catheter and pressure expandable stent system744 which includes all of the elements of the balloon expandable stentsystem shown in FIGS. 5G′-5G′″ and, in addition, may incorporate anendoscope or side lumen. Specifically, referring to FIG. 5P, there isshown a balloon catheter and pressure expandable stent system 744 thatcomprises a flexible catheter 746 having a balloon 750 and pressureexpandable stent 748 thereon. A side lumen 756 may be located on thecatheter 746 and an endoscope may be permanently positioned in ortemporarily inserted into (or through) such side lumen 756 to enable theoperator to view the balloon 750 and stent 748 and to advance thecatheter 749 to its desired position. Also, in embodiments thatincorporate a side lumen 756 such side lumen may be employed as aguidewire lumen to permit the catheter 746 to be advanced over aguidewire. Optionally, a lumen may extend through the catheter 746 andthrough an opening 752 in the distal end of the catheter 749 and astraight, curved, bendable, deflectable or steerable scope and/or stent754 may be passed through or received in that lumen to facilitate overthe wire and/or scope assisted and/or guided and/or manipulatedadvancement of the catheter 749 to an intended location. In routine use,the balloon 750 is initially deflated and the stent 748 is radiallycompressed to a collapsed configuration, around the deflated balloon750. The catheter 746 with the balloon 750 deflated and the collapsedstent 748 mounted thereon is advanced, under endoscopic guidance or overa guidewire, to a position within a passageway such as a nostril, nasalcavity, meatus, ostium, interior of a sinus, etc. that is to be stented.Thereafter, the balloon 750 is inflated causing the stent 748 to expandto a size that frictionally engages the surrounding tissue so as to holdthe stent 748 in place. In some instances the procedure will beperformed for the purpose of enlarging a passageway (e.g., an ostium,meatus, etc.) and the stent 748 will be expanded to a diameter that issufficiently large to cause the desired enlargement of the passagewayand the stent 748 will then perform a scaffolding function, maintainingthe passageway in such enlarged condition. After the stent 748 has beenfully expanded and implanted, the balloon 750 may be deflated and thecatheter 748 removed. In some applications, the stent 748 may contain adiagnostic or therapeutic substance as defined herein and such substancemay elute from the stent 748 into the surrounding tissue to bring abouta desired diagnostic or therapeutic effect. In some cases, the stent 748may be permanently implanted. In other cases the stent 748 may betemporarily implanted. In cases where the stent 748 is temporarilyimplanted, it may be removed in a second procedure conducted to retrievethe stent 748 or the stent 748 may be made of bioabsorbable orbiodegradable material such that it degrades or is absorbed within adesired period of time after implantation. As shown in the examples ofFIGS. 5R′ and 5R″, in some cases, such as when a stent is to be placedwithin the ostium of a paranasal sinus, the stent and/or the balloon maybe specifically shaped to facilitate and/or cause the stent to seat in adesired position and to prevent unwanted slippage of the stent. Forexample, FIG. 5R′ shows a device 1040 comprising a catheter 1042 havinga balloon 1044 and stent 1046 mounted thereon as described above.However, in this embodiment, the balloon 1044 and stent 1046 are of aconfiguration where one end of the balloon 1044 and stent 1046 is largerin diameter than the other end. As described above in connection withother embodiments such as those shown in FIGS. 5P and 5Q, a side scopeor side lumen 1048 may optionally be formed on the catheter 1042 and/ora scope or guidewire 1050 may optionally be passed through a lumen ofthe catheter 1042 and out of its distal end. FIG. 5R″ shows anotherdevice 1052 comprising a catheter 1054 having a balloon 1056 and stent1058 mounted thereon as described above. However, in this embodiment,the balloon 1056 and stent 1058 are of a configuration where both endsof the balloon 1056 and stent 1058 are larger in diameter than themiddle of the balloon 1056 and stent 1058. As a result, the stent 1058has an annular groove or indentation formed circumferentially or aboutthe mid-portion thereof or may be hourglass or venture shaped, tofacilitate seating of the stent 1058 within an ostium or orifice withoutlongitudinal slippage of the stent 1058. Again, as described above inconnection with other embodiments such as those shown in FIGS. 5P and5Q, a side scope or side lumen 1060 may optionally be formed on thecatheter 1052 and/or a scope or guidewire 1062 may optionally be passedthrough a lumen of the catheter 1054 and out of its distal end. In caseswhere the procedure is intended to actually break bone (e.g., where thestent 1046, 1058 is intended to dilate or enlarge a sinus ostium) thespecially shaped balloon 1044, 1056 may be made of strong polymericmaterial as described hereabove to enable it to exert bone-breakingpressure on the adjacent or surrounding bone as it is inflated.

FIGS. 5Q and 5Q′ show a self expanding stent and delivery system 760comprising a flexible outer sheath 762, a flexible inner tube 764 and astent 768. This stent differs from the stent 748 of FIG. 5P only in thatit is resilient and self-expanding rather than pressure expandable. Thestent 768 is biased to an expanded configuration. Initially, it iscompressed to a radially collapsed configuration on the outer surface ofthe inner tube 764 and the outer sheath 762 is advanced over the stent768 to constrain the stent 768 in its collapsed configuration, as can beseen in the cross-sectional showing of FIG. 5Q′. A scope and/orguidewire 770 may be inserted through the lumen of the inner tube 764.Additionally or alternatively, a side lumen 772 may be located on theouter sheath 762 and an endoscope may be permanently positioned in ortemporarily inserted into (or through) such side lumen 772 to enable theoperator to view the distal portion of the system 760 and the area aheadof the distal end of the sheath 762 as the system is advanced. Also, inembodiments that incorporate a side lumen 772 such side lumen 772 may beemployed as a guidewire lumen to permit the system 760 to be advancedover a guidewire. In routine operation the system 760, with its sheath762 in a distally advanced position such that it surrounds andconstrains the collapsed stent 768, is advanced, under endoscopicguidance and/or over a guidewire, to a position within a passageway suchas a nostril, nasal cavity, meatus, ostium, interior of a sinus, etc.that is to be stented. Thereafter, when the stent 768 is positioned atthe location to be stented, the sheath 762 is withdrawn, allowing theself-expanding stent 768 to spring or self expand to a radially expandedconfiguration in which it frictionally engages the surroundinganatomical structure. Thereafter, the remainder of the system 760 isremoved, leaving the stent 768 implanted in the body. The stent 768 mayperform dilation and scaffolding and/or substance delivery function(s)as described hereabove with respect to the pressure expandable stent 748of FIG. 5P.

FIG. 5S shows a snare apparatus 780 comprising a flexible catheter 782having a lumen 784 extending therethrough. A snare 786 having a generalloop shape is advanceable out of the lumen 784 of the device 780. Insome embodiments, the snare 786 may optionally be charged withelectrical current or otherwise heated so that it performs acauterization function as it cuts through tissue. Additionally oralternatively, in some embodiments, the snare 786 may be of variablediameter (e.g., a noose that may be tightened or loosened by theoperator). Also, optionally, a scope or side lumen 788 may be located onthe catheter 782 and a stationary or moveable endoscope may bepermanently embodied in or temporarily inserted into (or through) suchside lumen 788 to enable the operator to view the distal portion of thedevice 780 and the area of the snare 786. Also, in embodiments where thescope or side lumen 780 comprises a side lumen, such side lumen 788 maybe employed as a guidewire lumen to permit the device 780 to be advancedover a guidewire. Alternatively, multiple lumens may run throughcatheter 782 such that they can accommodate a snare, a guidewire and/oran endoscope. In routine operation, the snare 786 is initially retractedwithin lumen 784 and the device 780 is advanced under endoscopicguidance and/or over a guidewire, to a position within a passageway suchas a nostril, nasal cavity, meatus, ostium, interior of a sinus, etc.where a polyp or other matter to be snared or cut away is located. Thesnare 786 is advanced out of lumen 784 and positioned around the polypor other matter and, thereafter, the snare may be pulled or moved,heated (if equipped for heating) and/or tightened (if equipped fortightening) so as to sever or cut the polyp or other matter. In somecases, the severed polyp or other matter bay be suctioned through thelumen 784. In other cases, a separate catheter or device may beintroduced to retrieve the severed polyp or other matter. Aftercompletion of the procedure, the snare 786 may be retracted into lumen784 and the device 780 may be removed. Also, in some embodiments, thesnare 786 may be replaced by a basket, bag or other retrieval receptaclethat is useable to capture and retrieve tissue or other matter and towithdraw it into the lumen of the catheter 782.

FIG. 5T shows a forceps device 790 which comprises a flexible shaft 792having jaws or forceps 794 thereon. The jaws or forceps 794 may bevolitionally opened and closed by the operator. A scope or side lumen796 may be located on the flexible shaft 792, as shown. In embodimentswhere the scope or side lumen 792 comprises a scope, such scope may befixed or moveable and may be used to observe or view the advancement ofthe device 790 and/or the use of the forceps 794. In embodiments wherethe scope or side lumen 796 comprises a side lumen, a stationary ormoveable endoscope may be permanently embodied in or temporarilyinserted into (or through) such side lumen 796 to enable the operator toview the distal portion of the device 790 and the area of the forceps794. Also, in embodiments where the scope or side lumen 796 comprises aside lumen, such side lumen 796 may be employed as a guidewire lumen topermit the device 790 to be advanced over a guidewire. In routineoperation, the device 790 is advanced, either alone or through the lumenof a catheter, and possibly under endoscopic guidance and/or over aguidewire, to a position within a passageway such as a nostril, nasalcavity, meatus, ostium, interior of a sinus, etc. where matter is to begrasped by the forceps. Thereafter, under optional endoscopic guidanceand observation, the forceps 794 are used to grasp the intended matter.In some embodiments, a distal portion of the flexible shaft 792 may bebendable or steerable as indicated by doted lines on the example of FIG.5T. In some embodiments, the jaws of the forceps 794 may be designed tosever and retain a specimen of tissue for biopsy or other tissuesampling applications or the forceps 794 may comprise scissors forcutting tissue, cartilage, bone, etc. Alternatively, a lumen may passthrough flexible shaft 792 and exit through or next to the forceps 794and allow the passage of a guidewire or endoscope through such lumen.

FIGS. 5U and 5U′ show a telescoping system 800 comprising a flexiblecatheter 802, a flexible scope 804 and a guidewire 806. The flexiblescope 804 comprises a plurality of light transmitting pathways 808(e.g., optical fibers) that transmit light in the distal direction froma light source (not shown) and out of the distal end of the scope 804such that the light is cast onto the object or anatomical structure tobe viewed. Also, the scope comprises an image transmitting pathway 810(e.g., optical fiber and lens) that carries reflected light from distalend of the scope to an eyepiece or monitor on which the image may beviewed. The scope also has a guidewire lumen 805 extending therethroughand opening through its distal end. The scope 804 is advanceable throughthe flexible catheter 802 and a guidewire 806 that is advanceablethrough a guidewire lumen 805 of the scope, as shown. In routineoperation, the telescoping system 800 may be inserted into the nose andthe scope 804 may be utilized to view an anatomical structure, such asthe ostium of a paranasal sinus, and facilitate advancement of theguidewire into that anatomical structure. Thereafter, the scope may beadvanced over the guidewire and into the anatomical structure (e.g.,though the ostium and into the interior of the paranasal sinus). Thescope may then be used to examine the anatomical structure (e.g., toview the condition of the mucosa lining the paranasal sinus and to lookfor signs of infection, tumors, etc.) The catheter 802 may then beadvanced over the scope 804 and into the anatomical structure (e.g., thecatheter tip may be advanced through the ostium and into the paranasalsinus). Thereafter, the scope 804 may be removed and a diagnostic ortherapeutic substance as defined hereabove may be infused through thecatheter 802 and/or another working device, including but not limited tothe working devices shown in FIGS. 5A-5T and 5V-5Y′″″, may be advancedthrough the catheter 802 and into the anatomical structure where it isused to perform a diagnostic or therapeutic function.

FIG. 5V shows a side port suction/cutting device 820 which comprises aflexible outer tube 822, a flexible inner tube 830 is disposed coaxiallyand rotatably mounted within the outer tube 822. One or more bearings834 (e.g., a helical bearing or a series of individual cylindricalbearings) may be disposed between the outer tube 822 and inner tube 830,as shown. Alternatively, one or both apposing tube surfaces may be madeof, lined with, or be coated by etc. a lubricious material such assilicone or PTFE to facilitate movement. A rotating cutter 832 ispositioned on the distal end of the inner tube 830. A side opening 828is formed in the outer tube 822 and the cutter 832 is positionedproximal to the side opening 828. Optionally, a tapered atraumaticdistal tip 824 may be formed on the distal end of the outer tube 822 andthe side opening 828 may be configured to form a ramp or chute throughwhich matter may pass into the area immediately distal to the cutter832. Also optionally, an opening may be formed in the distal end of thedistal tip such that a guidewire or scope 826 may pass through the lumenof the inner tube 830 and out of the opening in the distal tip, asshown. In operation, the device 820 is advanced to a position where theside opening 828 is near a polyp, tissue or other obstructive matter tobe removed. The inner tube 830 and cutter 832 are rotated. Suction maybe applied through the lumen of the inner tube 830 and/or through thelumen of the outer tube 822 to draw the obstructive matter into the sideopening 828 and into contact with the rotating cutter 832. As theobstructive matter is severed by the rotating cutter 832, the severedobstructive matter or pieces thereof may be suctioned through the lumenof the inner tube 830 and/or through the lumen of the outer tube 822. Ofcourse, as in any of the working devices described in this patentapplication, a scope or side lumen of any size or length, into which ascope may be inserted (not shown in FIG. 5U but shown in various otherfigures such as FIGS. 5O, 5P, 5Q, 5R, 5S and 5T) may be attached to theouter tube 822 at a position which allows a scope to be used to view theside opening 828 and matter entering the side opening 828.Alternatively, the catheter may incorporate a deflectable tip or acurved distal end which may force the side opening of the catheteragainst a lumen wall or into the direction of a polyp or other tissue tobe removed.

In some applications of the invention, it may be desirable to breakbone, such as the thin bone that forms the periphery of a sinus ostium.FIGS. 5W-5X″″ show devices that may be used to break bones at specificlocations. For example, FIGS. 5W-5W″ show a device 840 that comprises aflexible catheter 842 having a rigid cylindrical member 847 located onthe distal end thereof. An advanceable and retractable member 846extends through the catheter 842 and is connected to a distal tip member844. The distal tip member 844 has a cylindrical proximal end 849 thatis sized to be received within the cylindrical member 847. As shown inFIGS. 5W′ and 5W″, in routine operation, the advanceable and retractablemember 846 is advanced to separate the distal tip member 844 from therigid cylindrical member 847. The device 840 is advanced to a positionadjacent to a bony structure, such as a structure formed by bone Bcovered with mucosal tissue M. The device is positioned such that thebony structure is between the cylindrical proximal end 849 of the distaltip member 844 and the cylindrical member 847. The advanceable andretractable member 846 is then retracted, pulling the distal tip member844 in the proximal direction and capturing the bony structure betweenthe cylindrical proximal end 849 of the distal tip member 844 and thecylindrical member 847, thereby breaking the bone B. The shape orconfiguration of the distal tip member 844 and/or cylindrical member 847may be varied depending on the shape and pattern of break desired to bemade in the bone B, In this regard, FIGS. 5X-5X″″ show alternativeconstructions or configurations that may be used to produce differentshapes and patterns of bone breaks. FIG. 5X′ shows an assembly 850comprising a distal tip member 852 that has three (3) projections on itsproximal side and a proximal member 854 that has three (3) notches inits distal surface, such notches being configured to receive the threeprojections of the distal tip member 852 when the distal tip member 852is retracted. FIG. 5W″ shows an assembly 860 comprising a distal tipmember that forms a pincher for breaking bone. FIG. 5X′″ shows anassembly 870 comprising a collapsible distal tip member 872 and acylindrical proximal member 874. The distal tip member 872 may beinitially deployed in a collapsed configuration that allows it to beadvanced through an opening such as the ostium of a sinus. Then, it maybe expanded to a size that is too large in diameter to pass through thatopening, thereby causing it to strike the periphery of the opening as itis retracted in the proximal direction. In this manner, the assembly5X′″ may be used to break bone B all the way around an ostium oraperture. FIG. 5X″″ shows another assembly 880 comprising a distal tip882 that has two projections on its proximal side and a proximal member884 that has one projection on its distal side. The projection on thedistal side of the proximal member 884 is received between theprojections formed on the proximal side of the distal member 882 whenthe distal member 882 is retracted in the proximal direction.

FIGS. 5Y′-5Y′″″ show various substance delivery implants that may beimplanted into the nasal cavities, paranasal sinuses, middle or innerear, nasopharynx, etc. to deliver a diagnostic or therapeutic substanceas defined herein. These devices may be formed of permanent orbio-absorbable material. In many instances, these devices will be formedof a polymer (e.g., Hydron, hydrogel, collagen, etc.) within which thediagnostic or therapeutic substance is contained or a polymer or metalthat is coated with or otherwise contains the substance. FIG. 5Y′ showsan implant 1070 that comprises a bead or pellet. FIG. 5Y″ shows animplant 1072 that comprises a wafer. FIG. 5Y′″ shows an implant 1074that comprises a brad or staple. FIG. 5Y″″ shows an implant 1076 thatcomprises a screw or helical coil. FIG. 5Y′″″ shows an implant 1078 thatcomprises a strand or coil, another example of which is shown in FIG. 7Eand described herebelow.

D. Pre-Shaped Guide Catheters

FIGS. 6A-6E show various guide catheters that may be used in the methodsof the present invention.

FIG. 6A shows a sphenoid sinus guide catheter 120 that incorporatesthree preformed curves 122, 124, 126. The three dimensional shape of thecatheter 120 is such that, when advanced through a nasal cavity, thedistal end of the catheter 120 will tend to enter the ostium of thesphenoid sinus.

FIG. 6B shows a frontal sinus guide catheter 128 that incorporates twopreformed curves 130, 133. The shape of the catheter 128 is such that,when advanced through a nasal cavity, the distal end of the catheter 128will tend to enter the ostium of the frontal sinus.

FIG. 6C shows a maxillary sinus guide catheter 136 that incorporatesthree preformed curves 138, 140, 142. The three dimensional shape of thecatheter 136 is such that, when advanced through a nasal cavity, thedistal end of the catheter 136 will tend to enter the ostium of themaxillary sinus.

FIG. 6D shows an ethmoid sinus guide catheter 144 that incorporates twopreformed curves 146,148. The three dimensional shape of the catheter144 is such that, when advanced through a nasal cavity, the distal endof the catheter 144 will tend to enter the ostium of the ethmoid sinus.

In some of the methods of the invention, it will be desirable to plugthe ostium of a sinus or another opening such as the nasolacrimal ductor the nasopharyngeal opening into the Eustachian tube. Thus, any of theabove-described guide catheters 120, 128, 136, 144 may be equipped witha plug on its distal tip such that when its distal end enters the sinusostium it will plug the sinus thereby preventing fluid from exiting thesinus through the ostium. An example of one such procedure is shown inFIG. 7B and described herebelow.

FIG. 6E shows a plug guide catheter 149 that is useable for temporarilyplugging the opening into a nasolacrimal duct. This plug guide catheter149 has two preformed curves 150, 152 and a plug 154 at its distal tip.The three dimensional configuration of this catheter 149 is such that,when advanced through a nasal cavity the distal tip plug 154 will tendto enter the opening into the nasolacrimal duct. The plug may consistof, but is not limited to, a semi-rigid plug or a balloon on the end ofthe catheter. It will be appreciated that a different shaped plug guidecatheter (not shown) may be used to plug the Eustachian tube.

E. Devices and Methods for Treatment Within Paranasal Sinuses:

FIGS. 7A-7G provide examples of devices and methods for performingdiagnostic or therapeutic procedures within the paranasal sinuses. Inthe methods of the prior art, rigid or flexible scopes are sometimesused to visualize the ostia of sinuses but, typically, such scopes havenot actually been advanced into the interior of the sinuses. Asdescribed hereabove, the present invention does provide devices andmethods for placing endoscopes inside the paranasal sinuses and suchmethods may or may not be used in conjunction with any of the diagnosticor therapeutic devices and methods shown in FIGS. 7A-7G.

FIG. 7A shows an electrode network delivery device 168 being used todeliver radiofrequency or electrical current to the lining of thesphenoid sinus SS. This device 168 comprises a flexible catheter 168that has been inserted through the sphenoidal sinus ostium SSO. Anexpandable electrode network such as a cage 170 is advanced out of thedistal end of the catheter 169. Electrodes 172 are positioned at spacedapart locations on the cage. As the cage 170 expands, it places theelectrodes in contact with the lining of the sinus SS. Current isdelivered to the electrodes 172 to ablate all mucous producing tissuewithin the sinus in preparation for the sinus to be functionallyisolated or embolized, or to ablate tumors or polyps located within thesinus.

FIG. 7B shows a procedure where a flowable substance, such as adiagnostic or therapeutic substance as defined above, is introduced intothe sphenoid sinus SS and the ostium SSO has been plugged by a sphenoidsinus plug guide catheter device 174. This device 174 comprises aflexible catheter 176 having the shape shown in FIG. 6A and describedabove and a plug member 178 at its distal tip. The fluid is maintainedin the sphenoid sinus SS until the plug catheter device 174 is removed,allowing the fluid to then drain through the sphenoid sinus ostium SSO.This procedure may be particularly useful when it is desired to fill asinus with radiographic contrast agent to visualize the entire sinus orto apply a therapeutic agent to the entire lining of the sinus byentirely filling the sinus with the agent and maintaining such fullyfilled state for a desired period of time to allow the agent to act onthe entire lining of the sinus. Imaging materials may be mixed withviscous agents so that they simulate mucous or if simple structuralimaging is desired it may be preferable to have substances of lowerviscosity. It may be also desirable to use imaging agents which bindwith the surface of the mucosa to minimize the amount of injectedcontrast.

FIG. 7C shows a balloon catheter device 180 which comprises a flexiblecatheter 182 having a balloon 184 that is positioned in the sphenoidsinus ostium SSO and inflated to hold the catheter 182 in position whilea quantity of a diagnostic or therapeutic substance 186 (as definedabove) is introduced into the interior of the sinus SS. This therapeuticsubstance may be one or more of any of the drug delivery materials anddrugs selected from the previous list, or may additionally include asclerotic agent such as alcohol to uniformly kill all the tissues withinthe cavity. Other materials such as capasian or other neuro-toxicsubstances may be considered to eliminate the pain and other sensationwithin the cavity.

FIG. 7D shows a sensor equipped catheter device 190 that comprises aflexible catheter 192 having a sensor 194 thereon for 3 dimensionalmapping or navigation. This procedure may be used to map the preciseconfiguration of the interior of the sphenoid sinus SS. Examples of theconstruction and use of such sensor 194 and associated systems/computersare found in U.S. Pat. Nos. 5,647,361; 5,820,568; 5,730,128; 5,722,401;5,578,007; 5,558,073; 5,465,717; 5,568,809; 5,694,945; 5,713,946;5,729,129; 5,752,513; 5,833,608; 5,935,061; 5,931,818; 6,171,303;5,931,818; 5,343,865; 5,425,370; 5,669,388; 6,015,414; 6,148,823 and6,176,829, the entireties of which are expressly incorporated herein byreference.

FIG. 7E shows an implant delivery device 196 which comprises a flexiblecatheter 198 that is inserted through the sphenoid sinus ostium SSO andinto the sphenoid sinus SS and is being used to implant a coil 200within the sphenoid sinus. Such coil 200 may comprise an elongate fiberor other elongate member that may contain a diagnostic or therapeuticsubstance as defined herein. This coil 200 may be constructed toembolize the sinus for the purpose of to permanently close off the sinusand to prevent any further mucous production, trapping of secretions orinfection and/or to deliver a diagnostic or therapeutic substance to thetissues lining the sinus. For example, a coil for sustained delivery ofan antimicrobial agent may be implanted in a sinus to treat an acute orchronic infection of that sinus. In some cases, the coil may bebioabsorbable.

FIG. 7F shows an over-the-wire endoscopic system 240 being used to viewthe interior of the sphenoid sinus SS. A flexible catheter 242 ispositioned in or near the sphenoid sinus ostium SSO and a guidewire 248is advanced through the sphenoid sinus ostium SSO and into the sphenoidsinus SS. An over-the-wire endoscope 246 (such as a 2.2 mm over-the-wirescope available commercially as Model #AF-28C from Olympus America,Melville, N.Y.) is advanced over the guidewire 248 and is used toexamine the interior of the sphenoid sinus SS.

FIG. 7G shows a biopsy system 250 being used to obtain a biopsy specimenfrom a lesion L within the sphenoid sinus SS. A flexible catheter 242 ispositioned in or near the sphenoid sinus ostium SSO and an endoscope 246is advanced through the catheter 242 and into the interior of the sinusSS. A biopsy instrument 252 is inserted through a working channel of theendoscope 246 and is used, under endoscopic visualization and guidance,to obtain a specimen of the lesion L.

F. General Examples of Interventions Using the Occluder & Access Devicesand/or Working Devices

FIGS. 8A-8D show two of many possible examples of methods wherein theoccluder & access devices 10, 12 of FIGS. 2A and 2B and/or variousworking devices such as those shown in FIGS. 5A-5Y″″ are used to performdiagnostic and/or therapeutic procedures within the nose, nasopharynx orparanasal sinuses.

In general, diagnostic interventions in accordance with this inventionmay include: a) anatomic studies where obstructions, sizes, parametersor abnormalities in anatomy are visualized and/or identified, b) dynamicstudies where gas, mucous or fluid is introduced into the nose, sinus,nasal cavity, nasopharynx, Eustachian tube, inner or middle ear, etc andthe movement of such materials is monitored to asses drainage or gasflow issues and c) perturbation studies where an agent (e.g., anallergen, irritant, agent that induces mucous production, etc.) isintroduced into the nose, sinus, nasal cavity, nasopharynx, Eustachiantube, inner or middle ear, etc., and the patient's response and/or flowof the endogenously produced mucous or other secretions is assessed.Examples of procedures that may be used to perform these types ofdiagnostic interventions include, but are not limited to, the following:

1. Gaining Access To Sinus: Access to one of more of the paranasalsinuses is gained by advancement of catheter(s) into the sinus orsinuses of interest. A guidewire may be inserted into the sinus firstand the catheter may then be advanced over the guidewire and into thesinus. In some cases, a sinus ostium guide catheter of the type shown inFIGS. 6A-6E may be inserted into the ostium of the sinus and a smallercatheter may be advanced through the guide catheter. One or more scopesmay be used to visualize the sinus ostium and to guide the guidewireand/or catheter into the sinus ostium. In some cases, a steerableguidewire, catheter and/or scope may be used to gain entry into thesinus. In some cases, occlusion & access device(s) such as those shownin FIGS. 2A-2R, may be inserted and the guidewire(s), catheter(s) and/orscope(s) used to access the sinus may be inserted through a deviceinsertion port on the occluder & access device.

2. Mucous Flow Study: Optionally, after catheter access to the sinus hasbeen gained, an imageable contrast substance or radioactive materialsuch as microbeads or a flowable contrast medium (e.g., an iodinatedcontrast solution with or without a thickening agent to adjust itsviscosity to that of mucous) that may have a consistency similar to thatof mucous may be injected into the sinus. An imaging or scanningtechnique (e.g., X-ray, fluoroscopy, CT scan, ultrasound, MRI, radiationdetector, gamma camera, etc.) may then be used to observe the flow ofthe contrast medium through and out of the sinus. In some cases afluoroscope with a C-arm may be used in a fashion similar to that usedin coronary artery catheterization and angiography procedures to allowthe clinician to view the movement of the contrast medium from differentvantage points or angles. To facilitate flow of the contrast medium fromthe sinus, the previously inserted catheter(s) and/or guidewires and/orscope(s) may be backed out of the sinus and ostium or removedcompletely, to allow normal flow to occur. The patient's head and/orother body parts may be repositioned to observe different posturaldrainage effects. In this manner, the clinician may specifically locateand identify which anatomical structures are obstructing or interferingwith normal mucous flow from the sinus.

3. Air Flow Study: Optionally, after access to the sinus has been gainedas described in No. 1 above, an imageable or traceable gas, such as aradiolabled gas, radiopaque gas or a gas with imageable or radioactivemicrobeads therein, may be injected through a catheter and into thesinus. An imaging device or tracing device (e.g., radiation detector,gamma camera, X-ray, fluoroscopy, CT scan, ultrasound, MRI) may then beused to observe subsequent movement or dissipation of the gas as itpasses out of the sinus and/or equilibrates with other sinus cavities.In this manner, the clinician may determine whether normal gas exchangein the sinus is occurring and may locate and identify any anatomicalstructures or irregularities that are obstructing or interfering withnormal gas flow and/or gas exchange.

4. Anatomic Dimension Study: An entire paranasal sinus or otheranatomical passageway or structure may be filled with an imageablesubstance or otherwise measured to determine its actual dimensionsand/or configuration. In some such studies, access to a paranasal sinuswill be gained as described in No. 1 above and the sinus may be filledwith an imageable substance (e.g., contrast medium). A suitable imagingtechnique (e.g., X-ray, fluoroscopy, CT scan, ultrasound, MRI, radiationdetector, gamma camera, etc.) may then be used to determine the size andshape of the sinus. Again, in such procedure, a moveable imagingapparatus such as a fluoroscope with a C-arm may be used to view andmeasure the contrast filled sinus from different vantage points orangles. One example of such a procedure is shown in FIG. 7B anddescribed hereabove.

5. Endoscopic Study: A flexible and/or steerable endoscope, as describedabove, may be inserted into the nose, sinus, nasal cavity, nasopharynx,Eustachian tube, inner or middle ear, etc and used to visually examinethe anatomy and/or to observe a treatment and/or to assess the efficacyor completeness of a previously rendered treatment. In cases where it isdesired to view the interior of a paranasal sinus, access to the sinusmay be gained as described in No. 1 above and the endoscope may beadvanced into the interior of the sinus either directly or over aguidewire.

6. Transillumination Study: A flexible light emitting instrument (e.g.,a catheter having a powerful light emitting apparatus at its distal end)may be advanced into the nose, paranasal sinus, nasal cavity,nasopharynx, Eustachian tube, inner or middle ear, etc and used toilluminate anatomical structures. Direct or endoscopic observation maythen be made from outside the body and/or from other locations withinthe nose, sinus, nasal cavity, nasopharynx, Eustachian tube, inner ormiddle ear, orbit, cranial vault, etc. to observe anatomical structuresand/or to detect aberrant openings or leaks through which the lightpasses. In cases where the light emitter and/or the viewing instrument(e.g., endoscope) is/are positioned within paranasal sinus(es) access tothe sinus(es) may be gained as described in No. 1 above and the lightemitter and/or viewing instrument may then be advanced into thesinus(es) either directly or over guidewire(s).

7. Other Imaging Studies: Other imaging techniques such as MRI, CT, etc.in combination with any of the modalities set forth in Nos. 1-6 aboveand modifications may be made to any of those techniques to adjust forsinus anatomy or other pathology.

After any or all of the elected diagnostic studies have been completed,one or more working devices, such as the flexible devices describedherein and shown in FIGS. 5A-5Y′″″, may, be inserted and used to performtherapeutic procedure(s).

As shown in the example of FIG. 8A, an anterior/posterior occluder &access device 10 is inserted through the right nasal cavity NC. Thedevice's anterior occluder 14 is positioned to occlude the nostril onthe right side while its posterior occluder (not seen in FIGS. 8A-8E)occludes the posterior choanae or nasopharynx. An anterior occluder &access device 12 is inserted into the left nasal cavity and its occluder40 occludes the left nostril. In this manner, a sealed operative fieldis established between the posterior occluder positioned in theposterior choanae or nasopharynx and the anterior occluders 14, 40positioned in the right and left nostrils or anterior nasal cavities.

FIGS. 8B-8C show an example of a method for performing a diagnosticand/or therapeutic procedure in the right frontal sinus FS in thepatient in whom the occluder & access devices 10, 14 have been inserted.In FIG. 8B, a frontal sinus guide catheter 128 is inserted into theworking device insertion port 30 and advanced through tube 16 and out ofoutlet aperture 22. The guide catheter 128 is then advanced to aposition where its distal end is in the right frontal sinus ostium.

In FIG. 8C, a working device 202 is inserted through the guide catheter128 and into the frontal sinus FS. This working device 202 may compriseany of the devices shown in FIG. 5A-5Y′″″ or 7A-7G. In some procedures,it may be desired to initially introduce a contrast agent into thefrontal sinus FS and pull back the guide catheter 128 to allow thecontrast agent to drain from the sinus. Imaging of the draining contrastagent may be used to diagnose drainage impairment and to identify thespecific anatomical structures that are causing the impairment ofdrainage. Thereafter, the guide catheter may be reinserted into thefrontal sinus ostium and the working device(s) 202 may be used to modifythe structures that have been identified and impairments to drainage.Thereafter, the contrast injection and imaging steps may be repeated toassess whether the procedure(s) performed have overcome or corrected thedrainage problem that had been initially diagnosed. A suction device 206is connected by way of suction line 204 to port 36 to suction blood,other fluid or debris from the operative field during the procedure.

FIGS. 8D and 8E show an example of a treatment rendered to the leftmaxillary sinus MS, in the same patient in whom the occluder & accessdevices 10, 14 have been inserted. In FIG. 8D, a guide catheter 136 isinserted into device insertion aperture 44 and advanced through tube 41to a position where the distal end of the guide catheter 136 ispositioned in the ostium of the maxillary sinus MS.

Thereafter, as shown in FIG. 8E, a working device 202 is insertedthrough the guide catheter 136 and into the maxillary sinus MS. Thisworking device 202 may comprise any of the devices shown in FIG. 5A-Y′″″or 7A-7G. In some procedures, it may be desired to initially introduce acontrast agent into the maxillary sinus MS by the same proceduredescribed above in reference to FIGS. 8B and 8C.

After all of the desired procedures have been completed, the anterioroccluders 14, 40 and posterior occluder (not shown on FIGS. 8A-8E) arecollapsed (e.g., deflated) and the occluder & access devices as well asthe guide catheters and working devices are removed (except for implantssuch as stents, embolic coils, substance delivery implants, etc.).

G. Cochlear Implant Procedure

FIGS. 9A-9C show a procedure for installation of a cochlear implant inaccordance with the present invention. In this procedure, thenasopharyngeal opening into the Eustachian tube ET is located and aguidewire is initially advanced into the Eustachian tube ET. A catheter900 is advanced over the guidewire to a location where the distal end ofthe catheter 900 is in or near the tympanic cavity TC of the middle ear.Thereafter, if deemed necessary, a forceps device 790 and/or otherdevices are advanced through the catheter 900 and used to remove thesmall bones of the sear (i.e., the malleus, incus and stirrup) as shownin FIG. 9A. This optional removal of the bones of the middle ear may bedone under endoscopic visualization using an endoscope equipped devicesuch as the endoscope equipped forceps device 790 shown in FIG. 5T anddescribed above. As shown in FIG. 9B, a cochlear guide catheter 904having a “J” shaped distal tip 905 is advanced through the catheter 900to a position where the tip 905 of the cochlear guide catheter 904 isdirected into or inserted into the cochlea C. In some applications, thecochlear guide catheter 904 may be configured to advance into the roundwindow of the cochlea and through the secondary tympanic membrane thatcovers the round window. If necessary, a penetrator such as a needle,drill or cutter may be advanced through or formed or positioned on thedistal end of the cochlear guide catheter 904 to penetrate through thesecondary tympanic membrane. In other applications, the cochlear guidecatheter 904 may be positioned adjacent to the cochlea and acochleostomy device (e.g., a penetrator such as a drill, needle orcutter) may be advanced through or formed or positioned on the distalend of the cochlear guide catheter 904 and used to form a cochleostomythrough which the distal end of the guide catheter 904 is advanced intothe cochlea C. Thereafter, a cochlear electrode array 906 is advancedthrough the cochlear guide catheter 904 and into the cochlea, as seen inFIG. 9B. One example of a commercially available cochlear electrodearray is the Nucleus 24 Countour device manufactured by CochlearCorporation.

Thereafter, a sound receiving device or transducer 908 is advancedthrough the catheter 900 and positioned in the tympanic cavity TC. Thesound receiving device or transducer 908 may be of any type that is a)sufficiently small to pass through the Eustachian tube ET and into thetympanic cavity TC and b) useable to perform the desired function ofconverting sound waves to electrical impulses and delivering suchelectrical impulses to the cochlear electrode array 906. Amicrophone/power/electronics device 910 may be positioned in the outerear canal, as shown in FIG. 9C or may be implanted subcutaneously or inany other way that is acceptable. Certain non-limiting examples ofdevices 906, 908, 910 that may be useable for this procedure are setforth in PCT International Patent Publication No. WO 2004/018980 A2designating the United States, the entirety of which is expresslyincorporated herein by reference.

It is to be appreciated that the invention has been described hereabovewith reference to certain examples or embodiments of the invention butthat various additions, deletions, alterations and modifications may bemade to those examples and embodiments without departing from theintended spirit and scope of the invention. For example, any element orattribute of one embodiment or example may be incorporated into or usedwith another embodiment or example, unless to do so would render theembodiment or example unsuitable for its intended use. All reasonableadditions, deletions, modifications and alterations are to be consideredequivalents of the described examples and embodiments and are to beincluded within the scope of the following claims.

What is claimed is:
 1. A device for removing polyps or other tissue fromthe nose, nasopharynx or paranasal sinus, said device comprising: aflexible catheter having a distal end and a lumen; a flexible tubehaving an open distal end and a lumen extending therethrough, saidflexible tube being rotatably disposed within a lumen of the cathetersuch that the flexible tube may rotate while the catheter does notrotate; a rotating cutter on the distal end of the flexible tube; and anopening formed in the catheter such that matter may be received throughthe opening and cut by the rotating cutter.
 2. A device according toclaim 1, further comprising a connector for connecting the lumen of theflexible tube to a source of negative pressure such that matter that iscut by the rotating cutter will be suctioned though the open distal endand through the lumen of the flexible tube.
 3. A device according toclaim 1 wherein the opening in the catheter is an opening in the distalend of the catheter.
 4. A device according to claim 1 wherein theopening in the catheter is a side opening formed in a side of thecatheter.
 5. A device according to claim 63 wherein there is at leastone bearing disposed between the catheter and the flexible tube.
 6. Adevice according to claim 63 further comprising a scope which is useableto view the distal end of the catheter while the device is inserted inthe body of a patient.
 7. A device according to claim 6 wherein thescope extends through the lumen of the flexible tube.
 8. A deviceaccording to claim 6 wherein the scope is attached to the exterior ofthe catheter.
 9. A device according to claim 6 wherein the scope isdisposed in a lumen on one side of the catheter.
 10. A device accordingto claim 1 further comprising a side lumen on the catheter.
 11. A systemcomprising a device according to claim 10 in combination with a scopepositioned in the side lumen.
 12. A system comprising a device accordingto claim 10 in combination with a guidewire positioned in the sidelumen.
 13. A device according to claim 4 further comprising moveableretractor apparatus that is operative to retract matter that has enteredthe opening into contact with the rotating cutter.
 14. A deviceaccording to claim 13 wherein the moveable retractor apparatus comprisesan elongate member having a retractor head, said elongate member beingadvanceable in a distal direction to move the retractor head to alocation distal to the side opening and retractable in the proximaldirection to move the retractor head in the proximal direction such thatthe retractor head will propel matter that has entered the opening intocontact with the rotating cutter.
 15. A device according to claim 13wherein the catheter has a closed distal tip.
 16. A device according toclaim 15 further comprising a lumen that extends through the flexibletube and through an opening formed in the distal tip of the catheter.17. A system comprising a device according to claim 16 in combinationwith a scope positioned within the lumen that extends through theflexible tube and through an opening formed in the distal tip of thecatheter.
 18. A system comprising a device according to claim 168 incombination with a guidewire positioned within the lumen that extendsthrough the flexible tube and through an opening formed in the distaltip of the catheter.